Location: Norwood, MA (100% Onsite)
Shift: M-F Day shift i.e 7-3, 8-4
Pay Rate: $30-33 per hour based on experience.
Make a Direct Impact on Next-Generation Therapeutics
Are you an experienced GMP operator looking to take the next step in your biotech career? Join an innovative life sciences team in Norwood, MA, where your precision, dedication, and attention to detail directly ensure high-quality medicine reaches patients in need.
We are looking for a Manufacturing Associate II to support cGMP labeling and packaging operations for parenteral drug product presentations, including vials and prefilled syringes.
- Execute Core Operations: Perform line setup, operation, and changeover support for labeling, cartoning, kitting, and case packing activities.
- Ensure Line Readiness: Perform room/equipment checks, line clearances, and controlled material staging to keep production running smoothly and compliantly.
- Maintain Label Control: Support label issuance, use, segregation, reconciliation, and documentation accuracy.
- In-Process Quality Checks: Conduct vision checks, print/scan verifications, and barcode verifications to ensure flawless execution.
- Documentation Excellence: Complete contemporaneous batch records and electronic logbooks using ALCOA+ principles.
- Cross-Functional Collaboration: Partner with QA/QC, MS&T, Engineering, and Supply Chain to resolve issues and drive continuous process improvements.
What You Bring to the Table
Basic Qualifications:
- High School Diploma / GED required; Associate’s or Bachelor’s degree in a scientific/technical field preferred.
- 1–3 years of experience in GMP manufacturing or regulated operations (pharma/biotech packaging/labeling experience strongly preferred).
- Experience with batch records, line clearance, in-process checks, and label reconciliation.
- Physical capability to stand for extended periods, wear required PPE/gowning, and lift up to ~35 lbs.
- Flexibility to work off-hours, weekends, or overtime to support production demands.
Preferred Skills:
- Solid understanding of cGMP regulations, SOP execution, and ALCOA+ documentation principles.
- Familiarity with digital manufacturing tools (MES/eBR, scanners, electronic logbooks, and labeling systems).
- Excellent communication and shift pass-down skills with a focus on timely escalation.
- Strong commitment to team collaboration, safe work practices, and 5S/housekeeping standards.
Why Work With Us?
- Collaborative Onsite Culture: Our 100% onsite model fosters real-time mentorship, strong team connections, and hands-on learning.
- Continuous Growth: Build your expertise across work centers in a fast-paced, high-tech manufacturing facility.
- Mission-Driven Environment: Be part of a workplace dedicated to highest quality, safety, and operational excellence.