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Kelly Services Quality Control Scientist in Somerville, Massachusetts

Quality Control Analyst – Somerville, MA

Full-time, Contract position – 12+ months

1 st shift

Pay - $35.00-$40.00/hr

Responsibilities:

  • Inspect, Review, and sample raw materials per approved specifications.

  • Support the shipment of samples to approved contract laboratories for testing.

  • Assist in generating material specifications, SOP revisions, change controls, deviations, investigations, RCAs, and CAPAs. Responsible for generating performance metrics, and trends.

  • As needed, support Implementation of continuous improvement (PPI) of GMP processes & support projects within the department and cross-functionally.

  • Review and approve material disposition packets.

  • Conduct/Support investigation of any process deviations, as needed.

  • Coordinate or conduct analyses of raw materials per established procedures.

  • Document work clearly, accurately, and in accordance with cGMP and regulatory Requirements.

  • Effectively partner with other BIO5 functions including QCRM, BIO5 QA, and Supply Chain to ensure timely resolution of issues.

  • As applicable, maintain laboratory and laboratory instruments and equipment and conduct the calibration.

  • Contribute to and improve quality procedures related to inspection, sampling, testing, and release of materials

  • Maintain Sampling supply inventory.

  • •Maintain Cleaning and upkeep of all sampling equipment and sampling room per in-house and regulatory guidelines.

  • Manage priorities and work schedules according to the demand and needs of other departments.

  • Work on Projects independently with limited supervision, as assigned.

  • Support multiple groups with QC and works closely with appropriate Manufacturing personnel to ensure timely resolution of issues.

  • Engage, develop and follow up the QCRM team with efficient direction and training of quality processes and procedures, while working towards goals and meeting performance metrics, to continuously improve standards and foster teamwork.

  • Perform other duties as assigned.

Education

  • A minimum of a Bachelor’s Degree is required in Chemistry, Microbiology, Biology, Pharmacy, Life Sciences or Engineering. Equivalent combination of education, training and relevant work experience may be considered.

Experience

  • Minimum of 2-5 years of experience in a GMP regulated industry, preferably biotech, pharmaceutical, or medical device

  • 2-5 years minimum experience in Quality Assurance, preferably Quality Control

  • Experience with key elements of the Quality system including change control, deviations and CAPA is highly desired.

  • Experience in writing, reviewing and approving GMP documents such as SOPs, Policies, etc.

#P2

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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