Quality Assurance Specialist

We are seeking a detail-oriented and motivated QA Analytical Specialist to join our Quality Assurance team. In this Junior-level role, you will support analytical quality team, contributing to review and approval of methods, data review, and compliance activities under cGMP guidelines. This is an excellent opportunity to build a foundation in pharmaceutical QA within a fast-paced CDMO setting.

Essential Functions and Responsibilities

·         Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents.

·         Performs review and release of stability and method validation data packets.

·         Review and approve Certificate of Analysis and/or Certificate of Conformance

·         Reviews and approves documents via eQMS (Master Control).

·         Support review of analytical data, laboratory notebooks to ensure accuracy, completeness, and compliance with cGMP requirements.

·         Assist in the investigation and documentation of laboratory out-of-specification (OOS) and out-of-trend (OOT) results.

·         Support review of instrument qualification and calibration documents.

·         Collaborate with QC and AD team to support timely lot release and client deliverables.

·         Assist in hosting and responding to clients and regulatory audits as needed.

·         Contribute to continuous improvement initiatives within the QA function.

Required Qualifications

•     Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related life sciences discipline.

•     0–2 years of experience in a pharmaceutical, biotech, or CDMO QA/QC environment (internship or co-op experience considered).

•     Foundational knowledge of cGMP, FDA 21 CFR Parts 210/211, and ICH guidelines.

•     Familiarity with analytical techniques such as HPLC, dissolution testing, Karl Fischer titration, and particle size analysis.

•     Strong attention to detail, data integrity mindset, and scientific documentation skills.

•     Proficiency with Microsoft Office Suite

Position Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, Forma provides employees with a variety of engaging employee and community outreach events.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Forma provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@formalifesciences.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

Forma is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Forma employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Forma. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.