2 дня назад
QC Manager, Microbiology
106 000 - 176 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Manager, Microbiology (cGMP/Pharmaceutical Quality Control): Leading microbiological testing operations and a QC Microbiology team supporting pharmaceutical product release, process control, and laboratory compliance with an accent on aseptic processing, contamination control, and operational excellence. Focus on maintaining inspection-ready laboratories, managing investigations and change initiatives, and implementing new technologies and continuous improvement methods.
Location: Onsite in Andover, Massachusetts, United States. First-shift Monday–Friday schedule, with occasional night, weekend, or holiday support. Permanent U.S. work authorization is required.
Annual base salary: $106,000–$176,600, plus a 15% bonus target and eligibility for a share-based long-term incentive program.
Company
develops and manufactures pharmaceutical products with a focus on safe, effective patient outcomes and science- and risk-based quality.
What you will do
- Lead routine microbiological testing supporting product release, process samples, product quality, and process control.
- Manage and develop QC Microbiology colleagues through goal setting, coaching, talent development, performance management, and succession planning.
- Maintain laboratory compliance with Quality Standards, regulatory requirements, and current cGMP, including audit and inspection readiness.
- Drive operational excellence through standard work, visual management, process optimization, metrics, trend analysis, and structured problem solving.
- Collaborate with Quality, Manufacturing, Technical Services, Supply Chain, and other site functions on production schedules, investigations, and strategic initiatives.
- Lead change initiatives, technology implementation, process improvements, and efforts to expand microbiology testing capabilities.
Requirements
- Bachelor’s degree with at least 4 years of experience; or master’s degree with at least 2 years; or PhD with 0+ years; or equivalent experience through an associate’s degree or high school diploma.
- Extensive knowledge of cGMP requirements for quality control laboratories and experience in pharmaceutical manufacturing quality operations.
- Experience with microbiological testing, laboratory operations, investigations, change management, aseptic processing, contamination control, and microbiological quality systems.
- Demonstrated experience leading teams, projects, or laboratory operations, with strong problem-solving, organizational, leadership, analytical, and communication skills.
- Must be authorized to work permanently in the United States. U.S. work visa sponsorship is not available now or in the future.
Nice to have
- Experience with statistical tools, root cause analysis, Six Sigma, QC laboratory instrumentation, method lifecycle management, and troubleshooting microbiological testing systems.
- Experience with new methodologies, technology transfer, regulatory inspections, and moderately complex cross-functional projects.
- Experience developing high-performing teams and sustaining continuous improvement initiatives.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot for problem solving, data analysis, communication, and productivity.
Culture & Benefits
- Quality culture centered on safety, compliance, accountability, continuous improvement, and colleague engagement.
- Comprehensive medical, prescription drug, dental, vision, and other health benefits.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver or parental leave, and medical leave.
- Relocation package eligibility is not provided for this role.
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