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Aerotek QC Analyst in Waltham, Massachusetts

A startup biotech is looking for an experienced Quality Control professional to join their team as a QC Analyst to support their novel target identification and validation workflow in-house. The ideal candidate should have relevant experience in gene therapy products, quality control, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

Responsibilities:

  • 1-3 month goal: Establishment/set up of the QC laboratory and analytical method transfer and qualification in preparation for Phase I clinical studies.

Specific responsibilities include but are not limited to: (expected assignment duration up to 6 months with possibility to apply for permanent role).

  • Coordinates execution of analytical methods and method transfer to the QC laboratory with the PAD team.

  • Generates SOPs based on the analytical methods.

  • Generates inventory of consumables, equipment and other QC materials needs.

  • Assists with generation of QC POs (equipment, materials).

  • Generates QC operations SOPs for the QC laboratory, that include but are not limited to equipment operation, cleaning, general laboratory maintenance.

  • Conduct routine/daily maintenance lab activities. Plans and performs Bio-Analytical testing such as Flow Cytometry, ELISA, qPCR, cell count, sterility testing BACT/ALERT (incoming, in-process and final product release testing).

  • Generates documentation for the maintenance and control of QC test samples as well as any test requests.

  • Ensures maintenance and control of QC test samples.

  • Maintains, controls, reagents, and reference standards inventory

  • Maintains retain and stability samples.

  • Performs Microbiological/sterility testing and activities in compliance with applicable SOPs and procedures.

  • Reviews/approves data generated by other team members.

  • Participates and conducts QA/QC training (cGMP/QC/QA procedures).

  • Contributes to the setup and optimization of the QC and Microbiology lab

  • Executes validation/optimization of test methods as per appropriate protocols in collaboration with PAD.

  • Participates in QC investigation/CAPA implementation (when applicable)

  • Supports and assists client Quality Assurance and Quality Control projects

  • Reviews QC documentation, to ensure completeness, accuracy, consistency, and clarity.

  • Generates/revises protocols/reports, SOPs, forms, laboratory data sheets.

  • Reviews, maintains QC laboratory documentation (logbooks, forms etc.)

  • Maintains the QC/Microbiology labs and associated equipment daily.

Requirements:

  • BA or MS in biology, chemistry, biochemistry, microbiology, or other related science

  • 3-6+ years of experience in QC - pharmaceutical, biologics, microbiology

  • Gene therapy product experience preferred

  • Industry knowledge of cGMP and GLP

  • Knowledge of other QC data systems (preferred)

  • Knowledge of bioassay test methods as defined in the “Responsibilities” section, as appropriate

  • Ability to communicate clearly and work collaboratively with a variety of individuals in various aspects of client operations

  • Detail-oriented with expertise in problem solving and solid decision-making abilities

  • Strong computer skills and written and verbal communication skills are essential

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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