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Senior Quality Control Analyst

Company: Randstad USA
Location: Hopkinton
Posted on: January 16, 2022

Job Description:

job summary:
Hopkinton based bioscience company that is a contract development and manufacturing services organization (CDMO) focused on cell-based therapies is actively seeking (1) Senior Quality Control Analyst who will be responsible for working under guidance of Manager responsible for optimization, qualification, transfer, and verification of analytical methods associated with cGMP production of cell therapy products. He/she will be responsible for writing/revising standard operating procedures (SOPs) in support of analytical methods. He/she may support equipment qualification and test method life cycle activities in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC testing activities as needed.

location: Hopkinton, Massachusetts
job type: Temporary
salary: $38.46 - 40.86 per hour
work hours: 9 to 5
education: Bachelors

Execute procedures for analytical methods in support of analytical method lifecycle.
Perform non-routine/routine QC testing as needed for in process samples, product testing, stability testing, or raw material testing.
Complete documentation for method development/qualification activities or QC testing in accordance with current Good Manufacturing Practices (cGMP).
Write and/or revise procedures, protocols, and reports in support of analytical methods for cell therapy products.
May participate in instrument qualification activities.
May participate in investigations, deviation, change controls, and CAPAs to support cGMP operations.
Work collaboratively with cross functional departments including but not limited to Analytical Development, Quality Assurance, and Program Management.

Bachelor's degree in scientific discipline
Minimum 5 years of analytical laboratory experience
Experience in a cGMP QC laboratory is desirable
Familiarity with analytical method lifecycle guidance (e.g., ICH) is desirable
Experience in ELISA required
ELISA method development and qualification experience a plus
Experience in qPCR, Flow Cytometry, cell-based assays, and/or microbiological methods a plus
Excellent/Effective written and verbal communications skills
Developed troubleshooting and problem-solving skills
Ability to adhere to timelines for testing and reporting of data
Ability to function in a team-oriented environment
Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities

skills: Quality control, Analytical Chemistry, Assay Development, Assay Method, Biology, Chemistry, Flow Cytometry, GMP (Good Manufacturing Practice)

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Keywords: Randstad USA, Worcester , Senior Quality Control Analyst, Professions , Hopkinton, Massachusetts

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