Sr. Manufacturing Associate I, Label & Packaging

Here's What You'll Do

• Execute packaging operations per approved SOPs and cGMPs, including (as qualified/assigned):
• Lead and/or execute line setup, operation, and changeover activities for labeling and packaging processes (e.g., label application, cartoning, kitting, aggregation/case packing where applicable), 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 where applicable) and take appropriate action within procedures.
• Complete accurate, contemporaneous documentation (ALCOA+), including logbooks, batch record entries, and electronic transactions (MES/eBR/labeling systems as applicable); 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; escalate gaps before processing begins.
• Identify, contain, and escalate deviations, atypical events, and equipment/system issues; perform intermediate troubleshooting within training and follow escalation pathways to reduce downtime and maintain compliance.
• Support shift-level investigation activities, CAPAs, and change controls for packaging-related events by providing factual timelines, observations, and clear documentation; may support implementation of corrective actions on the floor.
• Train, coach, and support qualification of associates through structured OJT, peer guidance, and demonstration of proper technique; promote consistent execution, cGMP behaviors, and safe work practices.
• Maintain compliance with gowning requirements (as applicable), controlled-area behaviors, safety protocols, and 5S/housekeeping standards; model safe and compliant behaviors for the team.
• Collaborate effectively with cross-functional partners during routine and non-routine operations (QA/QC, MS&T, Engineering, Supply Chain, Digital/Systems), including support of equipment readiness, engineering runs, and process improvement activities.
• Participate in and support continuous improvement activities related to safety, quality, documentation, throughput, reconciliation, and line performance.
• Flexibility to work off-hours, weekends, overtime, and different shifts as needed to meet production demands and business needs.

Here's What You'll Need (Basic Qualifications)

• 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 preferred.
• 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.

Here's What You'll Bring to the Table (Preferred Qualifications)

• 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 escalate 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.