The Manufacturing Associate II, Drug Product Label & Packaging is an experienced, hands-on operator supporting cGMP labeling and packaging operations for the company's parenteral drug product presentations, including vials and prefilled syringes. This role executes routine packaging activities under moderate supervision, supports line readiness and changeovers, maintains disciplined documentation and reconciliation practices, and develops proficiency within assigned work centers and procedures. This position emphasizes accuracy, right-first-time execution, strong documentation habits (ALCOA;), timely escalation, and teamwork to ensure packaged product meets quality, regulatory, serialization, and market requirements. Success looks like consistent execution under moderate supervision, clean and compliant line performance, routine issue identification and timely escalation, and steady development of proficiency within assigned work centers and procedures.
location: Norwood, Massachusetts
job type: Contract
salary: $30 - 34 per hour
work hours: 8 to 4
education: High School
responsibilities:
- Execute packaging operations per approved SOPs and cGMPs, including (as qualified/assigned)
- Perform line setup, operation, and changeover support for labeling and packaging activities (e.g., label application, cartoning, kitting, aggregation/case packing where applicable), ensuring correct configuration and readiness prior to start.
- Perform line clearances, room/equipment readiness checks, and controlled material/component staging to support compliant execution of packaging operations.
- Execute label control activities, including label issuance/use/return, segregation, reconciliation support, and disposition support per procedure; ensure counts and documentation are accurate.
- Conduct and document in-process checks and inspection/verification steps (e.g., barcode/label verification, vision checks, print/scan verification where applicable) and escalate issues per procedure.
- Complete accurate, contemporaneous documentation (ALCOA), including logbooks, batch record entries, and electronic transactions (MES/eBR/labeling systems as applicable); review own work for completeness and accuracy.
- Verify equipment status/readiness, including calibration labels, PM tags, cleaning status, and required pre-use checks.
- Identify and promptly escalate deviations, atypical events, equipment/system issues, and routine equipment or process issues per procedure and within training.
- Support packaging-related event documentation by providing factual timelines, observations, and documentation when requested.
- Assist with onboarding activities and demonstrate established procedures when requested, including proper technique, cGMP behaviors, and safe work practices.
- Maintain compliance with gowning requirements (as applicable), controlled-area behaviors, safety protocols, and 5S/housekeeping standards.
- Collaborate effectively with cross-functional partners during routine operations (QA/QC, MS&T, Engineering, Supply Chain, Digital/Systems), including support of equipment readiness, engineering runs, and process improvement activities as assigned.
- Participate in team discussions related to safety, quality, and operational improvements.
- Flexibility to work off-hours, weekends, overtime, and different shifts as needed to meet production demands and business needs.
qualifications:
Required
- High School Diploma / GED required; Associate's or Bachelor's degree in a scientific/technical field preferred (or equivalent experience).
- Typically 1-3 years of experience in GMP manufacturing or regulated operations preferred; labeling/packaging experience in pharma/biotech strongly preferred.
- Demonstrated ability to execute routine packaging work under moderate supervision while maintaining strong documentation practices (ALCOA).
- Experience with packaging batch records, line clearance, in-process checks, label control/reconciliation, and routine equipment or process issue escalation preferred.
- 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, SOP execution, ALCOA; documentation principles, and escalation requirements.
- Proficiency with basic digital tools used in manufacturing operations, which may include training systems, batch records, scanners, MES/eBR, labeling systems, and electronic logbooks.
- Strong attention to detail and ability to follow written procedures, work instructions, and batch record requirements precisely.
- Clear communication skills, including ability to provide accurate shift pass-downs and escalate issues in a timely, factual manner.
- Ability to work effectively in a team environment and support cross-training across work centers as needed.
- Visual acuity requirements as applicable to the role (e.g., corrected vision permitted); may require confirmation via vision/acuity testing per site practice.
skills: SOP Development, Good Manufacturing Practices (GMP), Aseptic Processing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
