QA Technician Jobs in North Carolina

Job Title: Quality Assurance Specialist Company: Becton Dickinson Location: Wilson, NC Description: The Quality Assurance Specialist as a member of the Quality Release group is responsible for performing detailed inspections of packaging components (primary and secondary) consisting of visual, mechanical and testing functions and is responsible for all associated paperwork and documentation .This position will also perform sampling of incoming raw materials for QC testing analysis. The Wilson quality system is compliant to 21CFR 210 211 and Becton Dickinson Corporate policies. This position will take direction and report to the Quality Release Leader.Main Responsibilities:- Member of the Quality Release group responsible for inspection of incoming components, finished product and batch documentation in compliance with 21CFR 210211, Becton Dickinson Corporate policies, and all other applicable quality / regulatory requirements- Performs detailed inspections of primary and secondary packaging materials and components using visual, mechanical, and instrumentation methodology- Perform detailed inspection of finished product samples using visual, mechanical, and instrumentation methodology- Perform sampling of incoming raw materials per inspection plan for QC testing- Generate all cGMP documentation associated with work activities- Enter data/results in SAP and/or SQL LIMS- Maintain work area and instrumentation in a clean, sanitary, orderly, operational and safe condition- Perform required standardization on measuring equipment- Assist in maintaining standard operating procedures- Performs other related Quality duties as assignedThe Quality Assurance Specialist as a member of the Quality Release group is responsible for performing detailed inspections of packaging components (primary and secondary) consisting of visual, mechanical and testing functions and is responsible for all associated paperwork and documentation .This position will also perform sampling of incoming raw materials for QC testing analysis. The Wilson quality system is compliant to 21CFR 210 211 and Becton Dickinson Corporate policies. This position will take direction and report to the Quality Release Leader.Main Responsibilities:- Member of the Quality Release group responsible for inspection of incoming components, finished product and batch documentation in compliance with 21CFR 210211, Becton Dickinson Corporate policies, and all other applicable quality / regulatory requirements- Performs detailed inspections of primary and secondary packaging materials and components using visual, mechanical, and instrumentation methodology- Perform detailed inspection of finished product samples using visual, mechanical, and instrumentation methodology- Perform sampling of incoming raw materials per inspection plan for QC testing- Generate all cGMP documentation associated with work activities- Enter data/results in SAP and/or SQL LIMS- Maintain work area and instrumentation in a clean, sanitary, orderly, operational and safe condition- Perform required standardization on measuring equipment- Assist in maintaining standard operating procedures- Performs other related Quality duties as assignedRequired Skills and Knowledge - Bachelors degree in a scientific discipline and 3 years of relevant Quality Assurance or an associates degree with 10 years experience in a pharmaceutical manufacturing company. Experience with visual inspection techniques, statistical sampling (ANSI Z1.4 Sampling Plan), ability to recognize defects in materials inspected, ability to work in a fast paced environment, ability to handle a high volume of work and rapidly adapt to changing environment. Prefer an associate trained in six sigma methodology.Technical Area of Expertise - Good verbal and written communication, organization, prioritization, displays sound judgment, interpersonal and computer competency to perform job. Experience performing investigations and displays good problem-solving skills

Job Title: QA Technician - $40K Company: Snack Foods Mfg Location: Charlotte, NC Description: QA Technician - $40K - AS Degree, BS preferred - Snack foods, Candy Manufacturing - Charlotte, NC job location - Plant position, not a lab job. Need (2) for off-shift positions. Requirements: QA Technician - $40K - AS Degree, BS preferred - Snack foods, Candy Manufacturing - Charlotte, NC job location - Plant position, not a lab job. Need (2) for off-shift positions.

Job Title: QA Specialist Company: Location: Greensboro, NC Description: We are currently seeking a QA Plant Label Specialist for a company in High Point, NC. Will be responsible for completeing all labeling documentation and providing labels to Finishing Department for all bulk cartons. Background check and drug test required. Must have previous experience in Quality Assurance. To appyl email resume to Register to View wiht QA Specialist in the subject line or fax resume to Register to View .

Job Title: Quality Assurance Specialist I Company: SunGard Public Sector, Inc. Location: High Point, NC Description: Job ID: 4642Position Description: SunGard Public Sector’s local government applications have been successfully delivering advanced, fully integrated solutions to public sector organizations for nearly thirty years. Our government information technologies address the business requirements of cities and counties, public and private utilities, public safety and justice agencies, and not-for-profit organizataions.Dedicated to serving municipalities worldwide, SunGard Public Sector’s market-leading products provide back-office integration, address wireless computing requirements of field personnel, and support the end-to-end delivery of electronic access to citizens and businesses.For public safety & justice agencies, SunGard Public Sector solutions offer system-wide integration and interoperability for computer-aided dispatch, records management, mobile computing, and jails management.The Software Quality Assurance Tester works closely and under the direction of the Quality Assurance Testing Team Leader. Software Quality Assurance Testers are responsible for the testing and functional validation of software applications.Responsibilities Include:• Validating development fixes and modifications• Provides advanced product support as needed (internal and external)• Provides new product functionality information to internal resources• Creates white paper documentation as needed• Identifies and enforces quality assurance standards• Create, maintain, and execute manual and automated test cases• Create test plans• Enters known issues into defect tracking system• Provides after hours emergency on-call support (rotation)• Reviews product documentation for accuracyPosition Requirements:Qualifications:• Software validation testing experience (black box) • Experience in test plan and test case development• Familiar with industry standard software testing methodologies (preferred)• Knowledgeable and skilled at writing test plan and test case• Understanding of relational database applications• Strong organization skills• Strong problem solving skills• Strong communication skills (written and verbal)• Ability to meet multiple deadlines in a multitasking environment• Working knowledge of MS SQL• Experience with MS Office Suite (Word, Excel, etc.)• MS Windows experience• Public Safety experience and/or knowledge of SunGard applications a plusEducation:Associate degree in computer technology related field (preferred) OR equivalent workexperience.Position Attributes:To apply for this position, please contact us at Register to View For more information about SunGard Public Sector, visit us at http://www.sungardps.com .Employment contingent upon successful completion of background investigation and pre-employment drug screen.SunGard Public Sector, Inc is proud to be an Equal Opportunity Employer!.

Job Title: Quality Assurance Specialists - Durham, NC Company: Merck Location: Durham, NC Description: Quality Assurance Specialists - Durham, NC Vaccine Manufacturing Start Up Job Quality Assurance Specialists - Durham, NC Vaccine Manufacturing Start Up:QUA001899DescriptionMerck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.As part of Merck's Quality Operations Organization, the Durham Quality team is seeking highly motivated individuals as Quality Assurance Auditors and Coordinators. These individuals will partner with Manufacturing Operations, Automation and Engineering as a member of one of two Integrated Process Team's (IPT) for the new Durham Vaccine Manufacturing Facility. The initial focus of most positions are to support start up projects in differing stages of progression dependant on the process supported. In 2010 the quality team will be hiring between 30 and 40 talented individuals for start up as well as ongoing quality support of aseptic GMP regulated vaccine manufacturing.The Bulk IPT will focus on the demonstration and ongoing quality support of a new live virus bulk facility supporting Chicken Pox and Shingles Vaccine manufacturing. The Formulation & Filling IPT will focus on the demonstration and ongoing quality support of a new formulation, lyophilization and filling operation for the MMR (Measles, Mumps & Rubella) Vaccine as well as Chicken Pox and Shingles Vaccines.QA Coordinator responsibilities include but are not limited to:* Facilitating the release of product and ensuring proper control of material* Review and approval of electronic batch records* Review and release of raw material, components and finished packaged product* Incoming supplies release* Sample management* Conduct periodic shop floor audits to ensure compliance* Direct in-line Quality support for all compliance, release and environmental monitoring matters* Review atypical investigations* Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations* Performing environmental sampling of aseptic areas, personnel and utility systems* Investigate OOS results and/or laboratory atypical events* Evaluate environmental data for adverse trends* SOP development and review* Direct support of regulatory inspections and audits* Direct support of validation activities and all other associated quality functionsQA Auditor responsibilities include but are not limited to:* Execution of internal and external audits* CBER and international product release* Coordination of divisional audits and regulatory inspections* Submission of annual product review data and information* Resolution of customer complaint investigations* Support of validation activities* Standard Operating Procedures (SOP) development and approval* Review of regulatory submissions* Support of Operational Excellence Initiatives* Completion and implementation of Regulatory Surveillance* Support of global Environmental Monitoring programQualificationsWhile all of the positions at Merck require a foundation of leadership behaviors, we are seeking individual contributors able to collaborate and effectively work in an empowered, self directed environment.Required:* Bachelor or Master degree in an Engineering or Science field* 2 to 8 years experience within a quality assurance role supporting a GMP manufacturing process or from a Manufacturing or Engineering role involved in quality functions supporting a GMP manufacturing process* Individuals graduating within the last calendar year or will graduate by spring 2010 with a Bachelor or Master's in Engineering or Science that have had an internship or co-op in a GMP manufacturing facilityPrefered:* Experience supporting a GMP aseptic process in a role that includes auditing compliance documentation such as APR's, SOP's, BPR's and Validation documents* Experience supporting a GMP aseptic process in a role that includes actively participating in Environmental Monitoring (taking samples and sample analysis)* Experience supporting a GMP aseptic process in a role that includes release responsibilities (raw material and final product release)* Experience supporting a GMP aseptic process in a role that includes deviation investigations and atypical reviewsOur employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # QUA001899. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.Search Firm RepresentativesPlease Read Carefully:Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.Primary Location:US-NC-Durham-RTPJob Type:Full TimeEmployee Status:RegularTravel:NoNumber of Openings:21Relocation Provided:None

Job Title: Sr. QA Associate Company: Kelly Scientific Resources Location: Clayton, NC Description: Kelly Scientific Resources is currently seeking an experienced senior QA associate for a pharmaceutical company in Clayton, NC. This opportunity is in the R&D QA team with a company that is consistently involved in some of the most innovative research within the pharmaceutical industry. This is a one year contract position. The work schedule is Monday through Friday, 8:00AM to 5:00PM.  QA Associate Responsibilities:- Independently contribute to R&D development efforts in the area of Medical Device Test System development. - Report to the Director of R&D QA. - Independently conduct in depth audits of internal groups and quality systems/processes for adherence to all applicable national/international regulations and guidelines, company policy, SOP's and industry standards. - Prepare and issue detailed audit reports to auditees, including Development management, study personnel, and CROs/vendors.- Review all audit findings and responses to the audit reports to assure that all observations have been adequately addressed. - Function as the key QA liaison to development efforts in the device areas supporting design control management, device history file management, change controls, clinical trials, product transfer activities and all activities supporting product licensure.  QA Associate Requirements:- BS (preferrably in science field)- 5-6 years of QA experience- Medical device quality system experience required- Biologics and/or drug experience preferredPlease apply online at www.kellyscientific.com or send resume to Register to View for immediate consideration. Kelly Scientific Resources® (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at www.kellyscientific.com

Job Title: Quality Assurance Associate Company: Novella Clinical Location: Durham, NC Description: Employer Information About Novella Clinical PharmaLinkFHI, the first U.S.-based eCRO, acquired Matrix Clinical and its therapeutic and in-country expertise. Together with eReady Monitors, our strengths have created Novella Clinical – the first global CRO – to integrate clinical and technological expertise to completely manage your clinical program. Because you see beyond the clinical trial. You strive to give people a better quality of life and more opportunities to enjoy life’s special moments. We’re proud to be a part of your missio....more info View all our jobs Job POSITION DESCRIPTION POSITION TITLE: Quality Assurance Specialist/Associate REPORTS TO: Director, Global Quality and Compliance BASIC FUNCTIONS: The Quality Assurance Specialist/Associate provides support to the Director, Quality, serving as an internal auditor, clinical site auditor, and/or vendor auditor, and as the document control coordinator for Novella. Assists the Director, Quality with implementation of Novella’s Quality Management System, to include ensuring compliance with Good Clinical Practice (GCP), HIPAA, and 21 CFR 11 regulations; ISO 9001: 2000 standards, and internal policies, procedures, and SOPs to manage and maintain regulatory compliance and clinical research information. AUTHORITY: • Has the authority to conduct and report assigned audits on behalf of management and clients in accordance with established audit processes. • Has the authority to issue and follow-up on audit findings and CAPA requests to individuals on behalf of management. • Has the authority to determine the need for and executes administrative changes to controlled documents. • Has the authority to make decisions concerning the administration of the document control system, determining which reviewer comments to include in changes, and to determine when administrative vs. full board approvals are necessary. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: • Maintains the Novella document control system and a tracking database, ensuring SOPs are updated as required; updating TOC as SOPs are revised/added; preparing SOPs for audits; reviewing/grading SOP training assessments and working with Directors to assure staff are adequately trained on SOPs; presenting SOPs at all corporate orientation sessions; notifying Novella staff of all revised/new SOPs as needed. • Acts as a lead auditor on the internal ISO audit team. Conducts internal quality system audits, acting as a lead auditor for assigned audits. Writes audit reports and submits to QA Director. Enters audit findings into the CAPA system and follows up on effectiveness of corrective actions. • Acts as clinical site auditor for contracted client site audits. Prepares audit plans, conducts audits, and writes audit reports for QA Director approval and submission to clients. When contracted, enters audit findings into the CAPA system and follows up with the audited site to ensure timely and effective actions. • Performs assigned vendor audits to ensure that Novella suppliers have suitable quality systems and meet required service expectations. Prepares audit plans, conducts audits, and writes audit reports for QA Director approval. Enters audit findings into the CAPA system and follows up with the vendor to ensure timely and effective corrective actions. • Manages the CAPA system. Receives, evaluates, and enters CAPAs into the database. Maintains CAPA files and follows up with owners to ensure timely responses are received. Verifies CAPA action effectiveness. • Assists the Director, Quality with coordinating and hosting Client and ISO registrar audit visits. Coordinates agendas, assists visitors with audit arrangements, takes and publishes audit minutes. Provides responses to auditors’ questions regarding QA processes and procedures, and coordinates activities with audit interviewees. • Prepares management information packages for quarterly Quality System Management Review Meetings, takes meeting minutes and publishes results. • Serves as a member of various internal and/or external teams, committees, or groups, representing the Novella Quality Assurance function. • Assists in the initial development and documentation of new or improved processes and procedures, where appropriate. • Acts as backup to the QA Director, presenting ISO and QMS information during new employee corporate orientation. • Assists with performance of final QA review of proposals to ensure proper composition, spelling, grammar, consistency, coherence and sensibility. • Performs other duties as assigned. KNOWLEDGE, SKILLS AND ABILITIES: • Working knowledge of quality assurance auditing, to include ISO, GCP, and general good business practices. • Knowledge of general principles of document management systems. • Excellent technical writing skills and fine attention to details, to include composition, grammar, punctuation and spelling. • Good communication skills, both written and verbal, with all levels of staff, clients, and with the public. • Good organization and time management skills • Working knowledge of MS Word, Excel, PowerPoint, and Access • Knowledge of Windows environment and the Internet. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: • Ability to travel domestically and internationally. • Very limited physical effort required to perform normal job duties. CLASSIFICATION: This position is exempt from the Fair Labor Standards Act, and incumbent employees are not eligible to receive overtime compensation. NOTES: Local Residents Preferred (No Relo)

Job Title: QA Technician Company: Kelly Scientific Resources Location: Charlotte, NC Description: Quality Assurance Technician - cGMP Validation Kelly Scientific Resources currently has an excellent contract-to-hire opportunity for a contract sterilization services company located in the Charlotte, NC area.  Our client is the global leader for contract sterilization solutions for the pharmaceutical and medical device industries.  This position will require working a 1st shift schedule including two weekends/month, but not more than 5 days/week.   Candidates will be responsible for the following duties:·         Provide data that is used by both plant and corporate management to determine if the quality system is adequate and operating as designed.  ·         Provide data and assist with corrective actions and continuous improvement.·         Effectively interface with Customer Service, Sales, Operations, Engineering and other plant and corporate staff, as well as customers and regulatory personnel.·         Assisting the Validation Coordinator with validations and calibrations.·         Monitors the quality and integrity of information required for the sterilization process history record (batch records).·         Issuing release of processed materials.·         Assisting with audits to ensure FDA/ISO/GMP compliance and to provide basis for continuous improvement.·         Add support for the review monthly quality management reports.·         Responsible for executing equivalency and retrospective re-validation studies/reports.·         Analyzing temperature and humidity probe data. Educational RequirementsA.S. degree preferred in a related scientific discipline, HS Diploma required.1-3 years experience with cGMP regulationsPreferred QA experience in pharmaceutical or medical device production environmentAbility to wear and use a respirator (previous respirator experience not required).Ability to lift 50 lbs. Please apply online at www.kellyscientific.com or send resume to Register to View for immediate consideration.  Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim.  Please visit us at www.kellyscientific.com to learn more.  Kelly Services is an Equal Opportunity Employer.

Job Title: Quality Assurance Technician II Company: Cascade Die Casting Location: High Point, NC Description: QUALITY ASSURANCE TECHNICIAN II Cascade Die Casting Group, Inc. has a challenging opportunity for a Quality Assurance Technician II for 2nd shift. The position will be located at our Atlantic Division in High Point, NC Responsibilities Will Include: l Maintain Quality Document System l Test and inspect products at various stages of production l Compile and evaluate statistical data to determine and maintain quality of products l Select products for testing at specific stages in production process l Test products, record data using statistical quality control procedures, and prepare data in graph or chart form l Evaluate data and write summaries regarding data l Participate in solving quality and productivity problems Experience Requirements: l Experience reading blueprints, using inspection gauging and measuring equipment. l Two years experience with SPC and Problem Solving techniques l Two years experience with use of process/product gauging techniques, spectrographic and fluoroscopic equipment l Demonstrated communication skills. l Knowledge of computers CDC offers a competitive wage based on experience with a comprehensive benefit package. To learn more about this opportunity, candidates should send a resume to: Register to View -cdc.com or Cascade Die Casting Group, Inc. / Atlantic Division 1800 Albertson Rd. High Point, NC 27260 Attn: Human Resources

Job Title: Senior QA Associate I,II - Contract Manufacturing Company: Dendreon Corporation Location: Research Triangle Park, NC Description: Dendreon is seeking a highly motivated Senior QA Associate, to be located in our North Carolina office, as part of our Quality Assurance Contract Manufacturing team. Dendreon is a fast-paced, high-volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position, which will develop and implement Quality Assurance policies and procedures in support of commercial manufacturing of Dendreon’s Active Pharmaceutical Ingredient. General Summary: Review and disposition contractor batch records promptly and effectively.Provides on-site quality oversight at contract manufacturer.Tracks and trends deviations, non-conformances, corrective actions, OOS, change controls, investigations and other metrics in support of management review.Provides support in the review and approval of change controls related to materials management.Works effectively to support all QA groups, providing assistance in performing data audits, processing deviations, non-conformances and CAPAs.Writes and reviews Standard Operating Procedures proactively, working with others to develop solutions.Develops and reports Quality metrics related to contract manufacturing sites.Maintains awareness of regulations (cGxP, CFR) and industry standards (USP, ICH, FDA guidance), ensuring Dendreon Quality is always aware of and addresses changes/revisions. Job Requirements: Bachelor’s degree in a scientific discipline or equivalent.Typically 5 years related experience in cGMP/FDA regulated industry (protein manufacturing preferred).Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.Proficient in MS Office applications. Working Conditions and Physical Requirements: Ability to gown aseptically for work in Clean Room environments.May be required to work alternate shifts and extended hours to meet project timelines.Some travel may be required to other Dendreon sites.This position is located full time at our North Carolina office. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.