QC Technician Jobs in Washington

Job Title: Senior QC Associate - Analytical Services Company: Dendreon Corporation Location: Seattle, WA Description: Senior QC Associate - Analytical Services Job Type: Regular Full-Time Location: Seattle, WA Job Description: Be part of an effective, enterprising and enthusiastic QC team! Dendreon is seeking a Senior Quality Control Associate in our Seattle Quality Control Department. This position is accountable for providing leadership and delivery of the corporate analytical method validation and transfer program objectives, in accordance with appropriate regulatory, corporate and scientific guidelines. You'll never be bored while mastering exciting and diverse technical projects, preparing project plans and trending analytical data. The successful candidate will have the ability to function in a fast-paced, highly technical environment, and communicate effectively. General Summary: Develops validation and transfer plans for new and existing analytical procedures for the evaluation of small molecule, protein, and biological products generated in house and by external vendors. Performs trending of system suitability and assay validity parameters in support of method optimization, laboratory investigations, validation protocols, method transfers, or method troubleshooting. Generates reports and collaborates with Regulatory Affairs during data reporting to regulatory agencies. Adheres to good documentation practices to ensure data integrity and traceability. Job Requirements: Bachelorâ??s degree in Chemistry, Biochemistry, or other relevant scientific discipline. Typically a minimum of 5 years of related experience in a cGMP Quality Control department in an FDA regulated industry (drugs/biologics). Experience should include validation of some or all of the following: HPLC, UV spectrophotometry, bioassays, ELISA, SDS-PAGE, DNA threshold, peptide mapping, cell-based assays. Thorough knowledge of quality systems, cGMP/ICH/FDA regulations. Proficient in MS Office, experience with Microsoft Project and Visio preferred. Working Conditions and Physical Requirements: Limited use of laboratory equipment, chemicals, and biological materials. 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.

Job Title: Senior QC Associate - Stability & Assay Validation Company: Dendreon Corporation Location: Seattle, WA Description: Be part of an effective, enterprising and enthusiastic QC team! Dendreon is seeking a Senior Quality Control Associate in our Seattle Quality Control Department. This position is accountable for providing leadership and delivery of the corporate stability and method validation and transfer program objectives, in accordance with appropriate regulatory, corporate and scientific guidelines. You'll never be bored while mastering exciting and diverse technical projects, preparing project plans and trending analytical data. The successful candidate will have the ability to function in a fast-paced, highly technical environment, and communicate effectively. General Summary: Performs review and trending of data in support of stability, method validation/transfer studies, investigations, specification justification and shelf-life of small molecule, protein and biological products generated in house and by external vendors.Performs trending of system suitability and assay validity parameters in support of method optimization, investigations, validation protocols, method transfers or method troubleshooting.Generates reports and collaborates with Regulatory Affairs during data reporting to regulatory agencies.Reviews data generated by various functional areas in support of characterization studies and change controls. Data review will include some or all of the following: HPLC, Flow cytometry, UV Spectrophotometry, bioassays, ELISA, SDS-PAGE, peptide map.Adheres to good documentation practices to ensure data integrity and traceability. Requirements: Bachelor’s degree in Chemistry, Biochemistry, or equivalent.Typically 5 years of related experience in a cGMP Quality Control department in an FDA regulated industry (drugs/biologics).Thorough knowledge of quality systems, cGMP/ICH/FDA regulations.Proficient in MS Office applications and statistical software such as JMP, SAS, StatLIA, Minitab, etc; experience with Microsoft Project and Visio preferred. Working Conditions and Physical Requirements: Limited use of laboratory equipment, chemicals, and biological materials. 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.

Job Title: Quality Control Technician Company: Medtronic Location: Redmond, WA Description: Responsible for the disposition submittal and product impact assessment of material discrepancies found in incoming inspection, warehouse, and manufacturing. Position Responsibilities Investigates the cause of rejection with the initiator of the NC / NCR as appropriateDocuments the product impact assessment and determines if further action is required Contains existing inventory to prevent recurrences as necessaryAssigns disposition to rejected lots and includes all supporting documentation, pictures, specifications as justification rationale Participates in identifying Root Cause Analysis of the nonconformanceRequest missing documentation directly with Suppliers Coordinates dispositions with internal customers and Suppliers as necessaryPerform inventory transactions to release material out of MRB and physically transfers to staging queueApplies Statistical Tools and Techniques to monitor Supplier Performance and provides feedback to Supplier Quality and Management teamsFollow cGMPs and documentation with cross-references where appropriateEnsure proper material identification, segregation, and storagePerform quarterly cycle counts and/or inventory of Inspect and MRB location(s) as requiredMaintain timely flow of production materialWork closely with members of Manufacturing, Distribution, Engineering, and Quality to ensure good communication and coordination of activitiesContinually seek process improvements and make recommendations to ManagementStay current with all assigned training requirements in SABAPerforms other related duties as required

Job Title: QC Associate I/II- In vitro Biology Company: Dendreon Corporation Location: Seattle, WA Description: Dendreon is seeking a Quality Control Associate I/II for our Seattle In vitro Biology Laboratory. This is an exciting position accountable for laboratory support of Dendreon’s products and in accordance with appropriate regulatory, corporate and scientific guidelines. The successful candidate will play a lead role in product testing, raw material testing and laboratory maintenance. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. Description: Performs and reviews in-process, final product and stability testing of Dendreon products in the In vitro Biology Laboratory (e.g. cell-based bioactivity assays, viral titer determinations, ELISA). Manages test samples, reagents and reference standards used in the laboratory. Ensures laboratory data integrity and traceability. Responsible for data/method performance trending; provide technical expertise during method optimization/validation studies. Provides technical expertise and testing support to other departments as part of cross-functional project teams. Assists with the coordination of QC training. Requirements: Associate’s degree in a scientific discipline or equivalent. Typically a minimum of 1 year experience in a cGMP Quality Control department in a FDA regulated industry (drugs/biologics). Extensive tissue culture and cell-based assay experience. Knowledge of cGMP/ICH/FDA regulations. Proficient in MS Office applications and MS Project. Experience with computerized systems (LIMS preferred). Working Conditions and Physical Requirements: Limited travel required Extensive use of laboratory equipment, chemicals and biological materials. 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.

Job Title: Senior Quality Control Associate - Analytical Services Company: Dendreon Corporation Location: Seattle, WA Description: Be part of an effective, enterprising and enthusiastic QC team! Dendreon is seeking a Senior Quality Control Associate in our Seattle Quality Control Department. This position is accountable for providing leadership and delivery of the corporate analytical method validation and transfer program objectives, in accordance with appropriate regulatory, corporate and scientific guidelines. You'll never be bored while mastering exciting and diverse technical projects, preparing project plans and trending analytical data. The successful candidate will have the ability to function in a fast-paced, highly technical environment, and communicate effectively. General Summary: Develops validation and transfer plans for new and existing analytical procedures for the evaluation of small molecule, protein, and biological products generated in house and by external vendors. Performs trending of system suitability and assay validity parameters in support of method optimization, laboratory investigations, validation protocols, method transfers, or method troubleshooting. Generates reports and collaborates with Regulatory Affairs during data reporting to regulatory agencies. Adheres to good documentation practices to ensure data integrity and traceability. Job Requirements: Bachelor’s degree in Chemistry, Biochemistry, or other relevant scientific discipline. Typically a minimum of 5 years of related experience in a cGMP Quality Control department in an FDA regulated industry (drugs/biologics). Experience should include validation of some or all of the following: HPLC, UV spectrophotometry, bioassays, ELISA, SDS-PAGE, DNA threshold, peptide mapping, cell-based assays. Thorough knowledge of quality systems, cGMP/ICH/FDA regulations. Proficient in MS Office, experience with Microsoft Project and Visio preferred. Working Conditions and Physical Requirements: Limited use of laboratory equipment, chemicals, and biological materials. 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.

Job Title: Quality Control Technician III Company: Kelly Automotive Services Grp Location: Seattle, WA Description: Quality Control Technician III Quality Control Technician - Kelly Scientific Resources is seeking QC Associates I/II for a Seattle Bioassay Laboratory, Shift II operations. This is an exciting position accountable for laboratory support of a unique cancer therapy vaccine in accordance with appropriate regulatory, corporate and scientific guidelines. Successful candidates will assist with testing and general laboratory maintenance Candidates will be responsible for: Performing, as assigned, in-process and final product testing of products e.g. flow cytometry, ELISA, endotoxin, Gram stain, complete blood count, viability, sterility by BacT/Alert . Analyzes test data to ensure accuracy, and uses good judgment to identify outliers, anomalies and test validity. Troubleshoots problems with test equipment and specific test batches. Receives and maintains test samples, reagents and reference standards used in the laboratory per approved procedures. Adheres to good documentation practices to ensure data integrity and traceability. Performs routine equipment and laboratory maintenance. Successful candidates will have two years of cGMP experience, an Associate s degree or higher in a scientific discipline or equivalent, be proficient in MS Office applications and preferably have LIMS experience. This is a Direct Hire opportunity that requires employee to work the second shift. If you are interested please send resume to 6245 kellyScientific.com and place job name in the subject line of your e-mail. Kelly Scientific Resources is a global scientific staffing organization dedicated to helping scientists of all levels, from entry level to PhDs, advance their careers in industry. We have multiple opportunities available with industry leaders in environmental science and consulting, biotech/pharmaceutical, food science, and manufacturing. Click Apply Now to be considered for all positions meeting your qualifications Learn more at www.kellyscientific.com Kelly Services is an Equal Opportunity Employer.