Quality Control Associate

Apex Systems Cambridge , MA 02138

Posted 3 weeks ago

Job Description: Job #: 994862

Quality Control Associate 994862

Job Scope & Purpose:

Our Cambridge based client focused on autoimmune disease, is seeking a talented and detail-oriented Quality Control Associate to join its growing team. This position will perform QC tests for pre-clinical and clinical material from specific manufacturing steps associated with their lead platform, from cell bank thaw through fill/finish. QC testing will include stability tests for cell banks and final product, in-process manufacturing tests and final product lot release tests. The right candidate will be expected to assume additional QC testing responsibilities associated with specific projects (e.g. cold chain custody qualification, in-use stability testing, etc). This role will move very quickly for the right person, apply now to learn more!

Primary Job Responsibilities:

  • Perform immunocytochemistry, flow cytometry assays and cell counts and viability on drug substance for product release

  • Perform qPCR testing for a variety of test articles.

  • Perform IOP/Q of quality control equipment.

  • Interpret and analyze results using statistical software packages (e.g. JMP) as appropriate.

  • Work with QC co-workers and health and safety department to ensure lab complies with regulations and all required training.

Primary Job Requirements:

  • Bachelor's degree in a related scientific field and three year's of Quality Control experience in a pharmaceutical or biotechnology cGMP setting, or Master's degree with a minimum of one year's experience.

  • At least one year's experience in a QC lab with each of the following methodologies: Immunocytochemistry/Immunofluorescence-particularly within a high content setting (96-well, 24-well plates) highly desired; flow cytometry; Molecular Devices ImageXpress Micro 4

  • Experience performing qPCR as well as experience working with a mycoplasma detection software package designed for real-time PCR is a plus

Preferred Qualifications:

  • ELISA experience is a plus

  • Experience with BacT Alert or comparable sterility test is a plus

  • Experience with Endosafe is a plus

  • Experience qualifying/validating QC assays is a plus

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.


Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

[ Link Removed ]

[ Link Removed ]

aweidman [ Link Removed ]

Code: RegQA

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] -6178.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Quality Control CMC

Bluebird Bio, Inc.

Posted 2 days ago

VIEW JOBS 12/5/2019 12:00:00 AM 2020-03-04T00:00 Director, QC CMC (Cambridge) We seek an experienced leader to direct our newly created Quality Control Chemistry, Manufacturing, and Controls (QC CMC) group. This Director-level position will oversee strategy of three areas: analytical product leads (APLs), stability, and specifications. The main objective of this role will be to ensure appropriate oversight and alignment of bluebird gene therapy products and regulatory filings as they relate to analytical release and stability testing strategy. This individual will be responsible for reviewing and/or approving CTD sections for lentiviral vector drug substance and autologous cell drug products, including specifications, justification of specs, batch analysis, stability, methods, method validation, reference standard, container closure, manufacturing controls and control of excipients. This highly visible cross-functional role will work with "client groups" within QC and interface with CMC teams, Product Teams, Quality Assurance, Supply Chain, Manufacturing, Process Development and other cross-functional teams. About the Role: * Lead, mentor, and develop three QC subgroups (Analytical Product Leads, Stability, Specifications) with up to 15 staff * Oversee CMC authoring/reviewing/approving of clinical and commercial filings (IND, IMPD, BLA, MAA) * Manage strategy for QC owned eCTD sections, agency interactions, queries for multiple Severe Genetic Disease and Oncology gene therapy products * Help to maintain harmonization of approach across product teams (analytical sections style, level of detail) About You: * MS, or PhD in a Chemistry, Biochemistry, or other related field * 15+ years in analytical development, QC, and/or regulatory affairs * Experience with both FDA and EMA (clinical and commercial) filings, agency interactions (written, telecon and/or in person), eCTD section authoring and reviewing * Ideal candidate would have biologic, gene therapy and/or autologous cell product experience * Highly developed communication skills and emotional intelligence to build relationships both within bluebird, and with regulatory agencies * Demonstrate a strong initiative and scientific leadership * Superb organizational, analytical, and communications skills and "do-what-it-takes" attitude * Self-directed and able to work with limited direction in a fast-paced, goal-oriented environment * Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself Bluebird Bio, Inc. Cambridge MA

Quality Control Associate

Apex Systems