BSA Lead Production Technician

Main Responsibilities

• Perform production in accordance with business needs and effective procedures.
• Ensure all materials required for production are available prior to need.
• Ensure completion of sampling and corresponding documentation.
• Complete move tickets and picklists accurately and on time to ensure accurate inventory.
• Resolve production issues; understand next steps and guide others through the process.
• Understand the science behind process steps and technology.
• Ensure all facility areas are adequately covered at all times; seek and advise on next steps.
• Ensure team planning and ahead-of-schedule work where possible.
• Complete tasks and documentation as required by cGMP; complete at least one developmental class annually (including at least one outside core competencies).
• Become trained in all assigned training modules.
• Training coordinator/trainer: train and guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP to assure consistent, timely signoffs.
• Maintain qualified trainer status; comply with procedures to ensure safety of self and others.
• Participate in monthly safety meetings; utilize +QDCI boards; report safety issues/concerns/incidents/near misses; participate in safety walkthroughs.
• Provide input for safety improvements and corrective/preventative actions; lead safety team efforts and training on safety initiatives.
• Ensure production of a safe and efficacious product; maintain thorough working knowledge of cGMPs.
• Identify deficiencies and recommend improvements.
• Identify deviations; assist with investigations and root cause analysis.
• Complete quality documentation (deviation investigations, BPRs, logbooks, etc.) accurately and timely; review completeness and release commodities as required.
• Work with quality and technical services on deviations, change controls, documentation, and CAPAs; ensure effective solutions are implemented and trained.
• Participate/lead team and cross‑functional meetings; actively communicate improvement ideas, issues, and concerns; mentor team members.
• Lead operator/room lead/SME in BSA areas; ensure “right the first time” quality.
• May provide leadership across processing areas; may schedule assignments and drive continuous incremental improvements to reduce operator errors.
• Inform managers of production problems/concerns and recommend solutions.
• Ensure processes/operations are documented timely and accurately; understand end‑to‑end BSA process and related business areas.
• Break down problems using proven standard approaches; fully investigate root causes of deviations.
• Write/review/revise BPRs, SOPs, and SWIs as needed.
• Continually monitor production activities with emphasis on safety, quality, efficiency, and cost.
• Ensure site safety and HR policy compliance; coordinate repair, PMs, and calibration of equipment.
• All other duties as assigned.

• Experience in a cGMP area; prior/related experience recommended.
• Knowledge and access to systems: SAP (including key user access).
• Knowledge and access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews.
• Good mechanical and computer skills; detail oriented; mechanical aptitude, comprehension/retention, troubleshooting, and manual dexterity.

• HS equivalent and 5+ years in cGMP or pharmaceutical experience.
• OR Associate’s with 3+ years in cGMP or pharmaceutical experience.
• OR Bachelor’s with 2+ years in cGMP or pharmaceutical experience.

• Meet all Sr. Production Technician requirements.
• 1+ year leading teams in a production environment.
• 1+ year training others in cGMP tasks.

• Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
• At least 14 weeks’ gender-neutral parental leave.