Position Title:
QA Compliance Specialist
Work Location:
Waltham, MA 02451 (Hybrid 3 days on-site)
Assignment Duration:
12 months (Possible Extension)
Work Arrangement:
Hybrid (3 days on-site per week)
Position Summary:
The
Senior Product Quality Assurance (PQA) Analyst supports
Quality Assurance activities related to
Third Party Manufacturing (TPM) plants, ensuring compliance with
cGMP and
regulatory requirements.
Background & Context:
This function is also the
primary person to audit batch records for products manufactured by
TPM plants. This position will ensure that all
product, process or system related quality activities from
raw material inspection through shipment of final product are in compliance with
Corporate and governmental regulations.
Qualification & Experience:
- Bachelor's degree preferably in Engineering or Science
- Six years of experience within the pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations/communications skills. Ability to effectively communicate across all levels of the organization
Qualifications & Requirements / Skillset:
- Experience in open chain control and change control is important for this role.
- The role requires knowledge of investigation tools, as the candidate may need to manage investigations when issues arise.
- Candidates should have experience of managing investigations as part of their responsibilities.
- The position involves working closely with product managers and TPM managers, where responsibilities may slightly differ depending on the level of engagement.
- This role will work more closely with the quality organization and project activities, rather than with the manufacturing or technical organizations.
- The candidate is expected to be onsite three days a week.
- Candidates with strong qualifications are encouraged to apply, even if they are located outside the Massachusetts area.
Key Responsibilities:
- Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
- Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.
- Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
- Review and approve manufacturing directions to the production floor.
- Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
- Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
- Perform annual Product Quality Review according to global procedure to comply with regulatory requirements.
- Participates in Trend Review Board to monitor process track and trending.
- Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
- Generates detailed change management plans related to TPM plant changes to ensure intended results are achieved, including planning, risk analysis, and implementation.
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Spectraforce Technologies
Oct 06, 2025