QA Technician Jobs in Massachusetts

Job Title: Quality Assurance Specialist Company: Phase Forward Incorporated Location: Waltham, MA Description: Serve as integral member of the Quality and Regulatory Compliance group, focusing on administration of the corporate training program, oversight of QMS documentation, and performance of internal audits. Administration of corporate training program involves the following activities:Monitor global compliance to Corporate Training Policy Propose and implement needed corrective and preventive actionsMaintain role-based definitions of training requirements, enroll staff in computer-based-training programs, track staff training compliance to completionCreate online exams using Toolbook Instructor Report and escalate training compliance failures as applicable. Support customer audit requests for training records including review of training and ad hoc corrections to those requested records as necessary. Quality Management System Documentation Oversight and ComplianceManage master archives and version control for all Quality System Management procedural documents for all operational departments and acquisitions including archive and electronic storage of original signature documentsInitiate and drive to completion the review/revision of all QMS documents per plans and schedules Assume primary authorship or major contributor for specific procedural revisions as assigned Internal AuditsPrepare, conduct, and produce reports for process audits of key Phase Forward departments and workflows on a scheduled basis to confirm compliance with the established SOPsSuch audits include but are not limited to Information Technology, Development, Services, and Global Customer Care, and annual SOX testing.  Ensure all findings are resolved effectively in a timely manner.  Additional Responsibilities:Inform Director, Quality & Regulatory Compliance of any corporate non-compliance incidents or regulatory compliance issues, which may arise internallyAssist Director, Quality & Regulatory Compliance in preparation of audit responses, and maintenance of the audit database and metrics.Education and Experience Required: B.S./B.A. Degree in scientific discipline, with 3+ years of previous experience in quality assurance and systems in an FDA regulated or similar environment preferred. Experience with computerized document management systems, quality management systems, and software development life cycle processes required.  Working knowledge of relevant industry and government regulations including: 21 CFR 11, ICH GCPs, and Guidance for Industry-Computerized Systems Used in Clinical Investigations a plus. Special considerations: Candidate must possess effective communication skills, and proven abilities in interfacing with colleagues in a number of different departments and managing multiple projects/priorities. Must be methodical, well organized and detail oriented.  Individual must be highly self-motivated, readily adaptable to a fast-paced, multidisciplinary team-based environment and capable of working autonomously with little direct supervision. Position Title of Supervisor: Director Quality Regulatory Compliance FLSA/JC:  Exempt If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id Register to View -9672

Job Title: QUALITY ASSURANCE ASSOCIATE 1 Company: Adecco Location: Dedham, MA Description: Busy non-profit in Dedham is in need of an experienced Quality Assurance Associate, with 1 - 2 years experience to handle the following responsibilities:Reviews, assesses and monitors quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Assists operating entities in preparing for, hosting, and closing out internal and external inspections/audits as necessary. Perform all duties and responsibilities in compliance with SOPs, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, State and Local regulations.Qualifications: Associate's degree or equivalent related experience plus one year experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital, preferably in QA or QC. Demonstrated effective verbal and written skills. Good analytical and problem solving skills. Strong skills needed to advance compliance and quality in operations. Must display tact, diplomacy and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Attention to detail and ability to gain and maintain confidence of the regional management and operating staff. Strong verbal and written communications skills. Persuasive skill to achieve compliance with relevant procedures. Must protect the confidentiality of sensitive information in the department. Ability to negotiate and present quality information to operations and QA management and staff. Must operate as a team member. This is a long term temporary position.Adecco is the world leader in human resource solutions, with a comprehensive service offering that includes temporary & contract staffing, outsourcing, permanent recruitment, outplacement and career services, training and consulting. We seek those motivated to make change and know that as partners we can help them to shape and achieve their personal and professional goals. Please apply on-line at adeccousa.com and enter zip code 02169.

Job Title: QA Technician Company: Location: Boston, MA Description: QA Technician *3-5 Years of manufacturing experience *Knowledge of ISO, blueprints, schematics, documentation experience *Experience in inspecting incoming materials and final inspection *MS Office (Word, Excel, Outlook) *Experience in a battery or power supply manufacturing environment a plus *Temporary position with possibility of a permanent role *1st shift position **Please submit resume and cover letter, please include desired salary range

Job Title: Quality Assurance Specialist Company: Shire Pharmaceuticals, Inc. Location: Cambridge, MA Description: Primary Role: Routine management & coordination of GMP compliance systems and policies for Alewife facility. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Review of production records for compliance. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and HGT goals. Responsible for adhering to GMP regulations, cGMP’s, company policies, and DNA leadership capabilities. *Must be able to work Second Shift and occasional Weekends Responsibilities: Quality System management and improvement: 40% Record reviews: 60% of the time Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: Education & Experience Requirements: • A minimum of a B.S. degree in science or engineering with at least 3 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. • Excellent interpersonal skills and the ability to communicate well orally and in writing. Key Skills and Competencies: • Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe. • Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises. •Ability to work effectively in a fast-paced environment • Strong written and oral communication skills required • Good interpersonal skills required • Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities. • Teamwork skills essential • Strong organizational skills • Ability to multi-task in a dynamic environment with changing priorities • Strong work ethic • Ability to meet challenging timelines, in spite of obstacles. • Flexible Complexity and Problem Solving: Employee at this level is involved in a variety of tasks of low to moderate level scope and complexity. Candidate receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy. Responsible for implementing global QA approaches based on sound principles, international industry/regulatory standards, and robust scientific basis. Responsible for troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions. Internal and External Contacts: Contacts are primarily with other professionals in the group (quality), manufacturing, facilities and regulatory. Other Requirements: Must be flexible to work late shifts and weekends on ad-hoc basis. Key DNA Leadership Capabilities: proficiency/excellence in all Job Scope 2 capabilities • Accountability & Ownership • Delivering Excellence • Self-Knowledge • Judgment and Decision Making • Energy and Drive Apply to Shire

Job Title: Temp, Quality Assurance Associate III Company: Stryker Location: Hopkinton, MA Description: The Temp, Quality Assurance Associate III is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all Stryker Biotech products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Participates in the internal and vendor qualification programs and makes vendor assessment recommendations.• Reviews all manufacturing and support records to certify compliance with specifications and procedures. • Releases product based on Quality Assurance record review and approval by QA Manager. • Performs regular internal audits of Stryker Biotech Manufacturing facilities as a lead auditor.• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues.• Performs vendor audits as scheduled.• Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending.• Reviews and approves Validation / Technical Reports.• Reviews and assesses Corrective and Preventive Action Reports• Participates in Regulatory Inspections.• Other duties as assigned.

Job Title: Quality Assurance Specialist Company: Shire Pharmaceuticals, Inc. Location: Lexington, MA Description: Primary Role: This is a first shift position. The hours are Wednesday to Saturday from 0600 - 1630. Responsibilities include the issuance and review of batch records/labels, review of test results, and Unpurified bulk product disposition of licensed product. Perform on the floor batch record review. Interpret documentation to ensure operations meet requirements of cGMP, internal SOPs and company policies. The candidate will be required to differentiate between deviations and expected results and resolve compliance issues in a timely manner. The candidate will ensure cGMP documentation is correct, clear and consistent with corporate and regulatory standards. Actively partners with manufacturing operations, providing compliance and technical guidance, to ensure that product quality issues are identified and resolved in a timely manner through applicable quality systems. Perform analysis, identify issues and provide recommendations for compliance improvements. Perform Mfg walkthroughs and provide follow-up and guidance to ensure resolution of observation. Responsibilities: Direct responsibilities include: • Draft, revise and/or approve procedures as required • Review and approve batch production records, manufacturing logs, and QC test results in support of unpurified bulk disposition • Daily support of QA on the floor activities in support of manufacturing • Ensure that documentation and operations meet established requirements of cGMP’s, internal SOP’s and company policies • Initiate, review and approve deviations Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: Education & Experience Requirements: Requirements include: • Bachelor’s degree (BA/BS) in a scientific discipline with a minimum of 3 years industry experience in quality or operations including experience in cGMP, pharmaceutical/medical device systems. • This position is for a 4 / 10 hour-work day with one weekend day shift along with Holiday coverage. Key Skills and Competencies: • Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises Trackwise and LIMS experience a plus. • Ability to work effectively in a fast-paced environment • Strong written and oral communication skills required • Excellent interpersonal skills required • Adherence to domestic and international GMP regulations, cGMP’s, company policies, DNA leadership capabilities, performance management and department budget • Teamwork skills essential • Strong organizational skills • Ability to multi-task in a dynamic environment with changing priorities • Strong prioritization skills• Self-motivated and driven to independently accomplish department goals and objectives • Shire expects all employees to live the BRAVE values: - Build on Integrity: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment - Risk a “Risk”: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference. - Act on the Needs of Patients: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with. - Vie to Be Better Than Yesterday: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress everyday to avoid the complacency that prior success may bring. - Exemplify Trust & Openness: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges. Complexity and Problem Solving: • This individual will be the primary quality assurance representative on 1st shift and is empowered to make quality assurance decisions. • It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor. Internal and External Contacts: • Besides working closely with the QA Operations Group, this individual will work closely with the following groups: - Manufacturing - Facilities and Engineering Other Requirements: This is a shift position Wed Sat 0600 - 1630 Apply to Shire

Job Title: Sr Examiner & Quality Assurance Specialist Company: Liberty Mutual Insurance Company Location: Boston, MA Description: Advanceyour career at Liberty Mutual - A Fortune 100 Company!As a Sr Examiner you examine a full range of high exposure, complex files in all aspects of personal lines coverages including BI, Property, NF, etc. The Sr Examiner will ensure proper reserves are set and interprets coverages.Provides expert technical consultation, recommendations, and direction to Field and Regional claims operations.Assists in developing and implementing quality assurance programs to ensure high quality claims handling.Conducts CORE (Comprehensive Office Review and Evaluation) audits to monitor performance of regional effectiveness in branch office claims handling. Provides feedback to HO management regarding branch management.Analyzes claims reports (Self-Audits, APEX, ACES, BI, Pure Prem, etc.) to identify trends, problems, and effectiveness.Ensures Action Plans are addressing applicable trends. Makes recommendations in accordance with findings.Monitors branch office Self-Audits through analysis of claims reports, and ensures Action Plans are addressing applicable trends.Consults with various internal departments regarding specifics of high exposure claims, exposures, defenses, and handling of specialty claims, as well as compliance suits.Consults with and advises various internal departments regarding regulatory and insurance policy issues, and provides recommendations for changes.Coordinates Market Conduct State Exams with Regional branch office and assists in preparing appropriate responses to various state regulatory agencies as a result of studies.Leads and participates in various task forces as requested.May perform special projects as assigned.

Job Title: Senior Quality Assurance Specialist - GLP/GCP Company: Cubist Pharmaceuticals Location: Lexington, MA Description: Position Summary: Collaborates with Nonclinical and Clinical Research personnel to ensure that research practices comply with SOPs, regulations, and guidelines. Provides GLP and GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (domestic and international) GLP and GCP -related audits. Cubist GLP Contributing Scientist Report Audits Vendor Audist (CROs, Labs) Trial Master File (TMF) Audits System/Process Audits Investigator Site Audits Study Directed Audits Review nonclinical documents for adequacy and compliance, as required. Assists in the development and maintenance of quality management systems. Reviews SOPs to ensure compliance with applicable regulatory and corporate standards. Participates in the development and delivery of internal training programs. Assists management in the preparation for regulatory agency inspections. Supports the preparation, coordination, and management of regulatory agency inspections of Cubist. Supports 'for cause' audits, as necessary. Keeps up to date with current regulatory guidelines and regulations. Minimum Basic Qualifications : Bachelor s degree in a scientific discipline 5 years in a pharmaceutical quality assurance / compliance role At least 3 years experience in an GLP auditing role, with one year as a lead auditor Experience Required: Working knowledge of 21 CFR Part 58 Must be able to partner with a diverse group of staff/consultants with different strengths and skills Ability to prioritize work and handle multiple assignments, while maintaining quality Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Ability to work independently and as part of a team, detail oriented Excellent communication skills and investigative techniques Desired Competencies and Qualifications: Working knowledge of Code of Federal Regulations (CFR) and ICH Guidelines governing clinical research and familiarity with current initiatives One plus years in a GCP auditing role Working knowledge of 21 CFR Part 11 and Computer System Validation (CSV) Experience in international compliance / auditing Experience in developing and writing SOPs Auditor certification (ASQ, SQA) Work Environment: This position will be based in the Lexington, MA office Physical Demands: The candidate must be willing to travel (up to 50% during peak workloads) To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Title: Senior Quality Assurance Specialist - GCP Company: Cubist Pharmaceuticals Location: Lexington, MA Description: Position Summary: The Sr. QA Specialist assists in the development, implementation and management of Cubist R&D Quality Assurance programs and initiatives. Conducts internal and external audits to assess compliance with regulations and Cubist policies and procedures. Serves as Quality / GCP resource for clinical teams. Collaborates with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines. Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (domestic and international) GCP-related audits. Investigator Site Audits System/Process Audits Vendor Audits (CROs, Labs) Data Audits Trial Master File (TMF) Audits Document Audits (protocol, ICF, IB) Assists in the development and maintenance of quality management systems, from the GCP perspective. Reviews SOPs to ensure compliance with applicable regulatory and corporate standards. Participates in the development and delivery of internal training programs. Assists management in the preparation for regulatory agency inspections. Supports the preparation, coordination, and management of regulatory agency inspections of Cubist clinical research operations. During inspection, plays lead role as facilitator and communicator. Supports 'for cause' audits, as necessary. Keeps up to date with current regulatory guidelines and regulations. Minimum Basic Qualifications: Bachelor s degree in a scientific discipline 5 years in a pharmaceutical quality assurance / compliance role At least 3 years experience in an GCP auditing role, with one year as a lead auditor Experience Required: Working knowledge of Code of Federal Regulations (CFR) and ICH Guidelines governing clinical research and familiarity with current initiatives Knowledge of medical practice/techniques and terminology Must be able to partner with a diverse group of staff/consultants with different strengths and skills Ability to prioritize work and handle multiple assignments, while maintaining quality Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Ability to work independently and as part of a team, detail oriented Excellent communication skills and investigative techniques Desired Competencies and Qualifications: Working knowledge of 21 CFR Part 11 and Computer System Validation (CSV) Working knowledge of 21 CFR Part 58 and GLP auditing experience Experience in international compliance / auditing Experience in developing and writing SOPs Auditor certification (ASQ, SQA) Work Environment: This position will be based in the Lexington, MA office Physical Demands: The candidate must be willing to travel (up to 50% during peak workloads) To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Title: Senior Quality Assurance Specialist - GLP/GCP (6291) Company: Cubist Pharmaceuticals Location: Lexington, MA Description: 6291 Job Description Position Summary: Collaborates with Nonclinical and Clinical Research personnel to ensure that research practices comply with SOPs, regulations, and guidelines. Provides GLP and GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (domestic and international) GLP and GCP -related audits.  Cubist GLP Contributing Scientist Report Audits Vendor Audist (CROs, Labs) Trial Master File (TMF) Audits System/Process Audits Investigator Site Audits Study Directed Audits  Review nonclinical documents for adequacy and compliance, as required. Assists in the development and maintenance of quality management systems. Reviews SOPs to ensure compliance with applicable regulatory and corporate standards. Participates in the development and delivery of internal training programs. Assists management in the preparation for regulatory agency inspections. Supports the preparation, coordination, and management of regulatory agency inspections of Cubist. Supports 'for cause' audits, as necessary. Keeps up to date with current regulatory guidelines and regulations.  Minimum Basic Qualifications : Bachelor’s degree in a scientific discipline 5 years in a pharmaceutical quality assurance / compliance role At least 3 years experience in an GLP auditing role, with one year as a lead auditor Experience Required: Working knowledge of 21 CFR Part 58 Must be able to partner with a diverse group of staff/consultants with different strengths and skills Ability to prioritize work and handle multiple assignments, while maintaining quality Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Ability to work independently and as part of a team, detail oriented Excellent communication skills and investigative techniques  Desired Competencies and Qualifications: Working knowledge of Code of Federal Regulations (CFR) and ICH Guidelines governing clinical research and familiarity with current initiatives One plus years in a GCP auditing role Working knowledge of  21 CFR Part 11 and Computer System Validation (CSV) Experience in international compliance / auditing Experience in developing and writing SOPs Auditor certification (ASQ, SQA)  Work Environment: This position will be based in the Lexington, MA office  Physical Demands: The candidate must be willing to travel (up to 50% during peak workloads)  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Job Location Lexington, MA, US. Position Type Full-Time/Regular