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Job Requirements of QC Lab Systems Specialist:
-
Employment Type:
Contractor
-
Location:
Devens, MA (Onsite)
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QC Lab Systems Specialist
Careers Integrated Resources Inc
Devens, MA (Onsite)
Contractor
Job Title: QC Lab Systems Specialist
Job Location: Devens, MA
Job Duration: 3-4 Months (possibility of extension)
Shift: Sun - Wed, 6:00am - 4:00pm
Payrate: $66.00 - $71.00/ hr on w2
Job Summary:
Job Location: Devens, MA
Job Duration: 3-4 Months (possibility of extension)
Shift: Sun - Wed, 6:00am - 4:00pm
Payrate: $66.00 - $71.00/ hr on w2
Job Summary:
- Client is seeking a QC Specialist for QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA.
- The QC Specialist is responsible for supporting Quality Control analytical data review for in-process and final drug substance methods as well as supporting data trending and report generation.
- This includes the ability to interface with multiple groups, the ability to independently review, interpret results, troubleshoot, and initiate and own deviations.
- Perform data review for in-process and final drug substance methods in support of routine manufacturing following applicable procedures and SOPs.
- Perform routine data analysis including trending requirements and report generation to support quarterly data trending requirements.
- Initiate and own non-impact laboratory deviations.
- Document data GMP accurately and within the proper system.
- Anticipate and troubleshoot problems.
- Support document revisions, projects, and related tasks.
- Perform assigned tasks within a CAPA, deviation, or project.
- Participate in projects and continuous improvement efforts.
- Other duties as assigned.
- Bachelor’s degree required, preferably in science.
- 2+ years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute.
- Experience working in a GMP laboratory and with cell therapy products preferred.
- Experience with analytical laboratory testing techniques and deviations writing preferred.
- Hands on experience with various analytical techniques including FLOW Cytometry, and PCR based methods is preferred.
- Knowledge of aseptic technique within a laboratory environment is preferred.
- Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
- Strong technical writing skills.
- Problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers.
- Knowledge of LIMS and laboratory data analysis systems preferred.
- Shift: A1 - Sun - Wed, 6:00am - 4:00pm.
- Shift: A2 - Sun – Wed, 2:00pm - 12:00am.
- Shift: 1 Flex shift/Monday - Friday, 10:00am - 6:00pm.
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