Sr. Manufacturing Associate
Job in
Norwood, Norfolk County, Massachusetts, 02062, USA
Listed on 2026-07-02
Listing for:
Moderna Therapeutics
Full Time
position Listed on 2026-07-02
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Sr. Manufacturing Associate I, Drug Product Label & Packaging
The role supports cGMP labeling and packaging operations for Moderna’s parenteral drug product presentations.
Responsibilities- Execute packaging operations per approved SOPs and cGMPs.
- Lead and/or execute line setup, operation, and changeover activities for labeling and packaging processes, ensuring correct configuration and readiness prior to start.
- Perform and verify line clearances, room/equipment readiness checks, and controlled material/component staging to support compliant operations and minimize mix‑ups.
- Execute and verify label control activities, including label issuance/use/return, segregation, reconciliation, and disposition support per procedure; ensure counts and documentation are accurate and complete.
- Conduct and document in‑process checks and inspection/verification steps (e.g., barcode/label verification, vision checks, print/scan verification) and take appropriate action within procedures.
- Complete accurate, contemporaneous documentation (ALCOA+) including logbooks, batch record entries, and electronic transactions; review own work and support peer review for completeness and accuracy.
- Verify equipment status/readiness, including calibration labels, PM tags, cleaning status, and required pre‑use checks; escape gaps before processing begins.
- Identify, contain, and escape deviations, atypical events, and equipment/system issues; perform intermediate troubleshooting and follow escalation pathways to reduce downtime.
- Support shift‑level investigation activities, CAPAs, and change controls for packaging‑related events by providing factual timelines, observations, and clear documentation.
- Train, coach, and support qualification of associates through structured OJT, peer guidance, and demonstration of proper technique.
- Maintain compliance with gowning requirements, controlled‑area behaviors, safety protocols, and 5S/housekeeping standards.
- Collaborate effectively with cross‑functional partners (QA/QC, MS&T, Engineering, Supply Chain, Digital/Systems).
- Participate in and support continuous improvement activities related to safety, quality, documentation, throughput, reconciliation, and line performance.
- Provide flexibility to work off‑hours, weekends, overtime, and different shifts as needed.
- High School Diploma / GED required;
Associate’s or Bachelor’s degree in a scientific/technical field preferred (or equivalent experience). - Typically 3–5 years of experience in GMP manufacturing or regulated operations; labeling/packaging experience in pharma/biotech strongly preferred.
- Demonstrated ability to independently execute routine and complex work while maintaining strong documentation practices (ALCOA+).
- Experience with packaging batch records, line clearance, in‑process checks, label control/reconciliation, and basic to intermediate equipment/system troubleshooting.
- Ability to support training, peer coaching, escalation, and shift‑level problem solving in a compliant manufacturing environment.
- Comfort working in controlled environments with standing for extended periods, following gowning/PPE requirements, and performing repetitive tasks with high attention to detail.
- Ability to lift up to ~35 lbs (or per site standard) and perform physical tasks consistent with packaging operations.
- Working knowledge of cGMP expectations, ALCOA+ principles, packaging batch records, logbooks, and electronic manufacturing/labeling systems.
- Strong attention to detail with disciplined documentation, reconciliation, and line‑clearance habits.
- Clear communication skills with the ability to escape issues promptly and provide accurate handoffs.
- Ability to work effectively in a team environment and serve as a positive peer resource for newer associates.
- Demonstrated ownership mindset, reliability, flexibility, and commitment to safety, quality, and continuous improvement.
The salary range for this role is $74,000.00 – $. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
- Co…
Position Requirements
10+ Years
work experience
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