8 дней назад
Manager Quality Control I - Nights (Biotech)
11 406 320 - 15 432 080$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager Quality Control I - Nights (Biotech): Leading night-shift QC operations in a GMP-regulated laboratory, including sample management, analytical testing, manufacturing support, and compliant documentation with an accent on data integrity, laboratory systems, and shift-level risk management. Focus on independently performing chemistry, bioassay, or microbiology testing, supporting deviation and OOS investigations, and maintaining testing timelines during Wednesday–Saturday night shifts.
Location: Holly Springs, North Carolina, United States. Onsite Wednesday–Saturday night shift schedule.
Annual salary: USD 114,063.20–154,320.80.
Company
is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead night-shift Quality Control operations, including sample receipt, prioritization, and accurate LIMS entry.
- Act as the primary QC contact for Manufacturing, supporting production schedules, issue resolution, and risk escalation.
- Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing when required.
- Maintain compliant documentation under GDP, GMP, and 21 CFR Part 11 requirements.
- Support investigations into deviations and OOS results and communicate shift-level risks to QC leadership.
- Use LIMS, Biovia LES, ELN, CIMS/CISPro, and Veeva Vault while contributing to cross-functional improvement initiatives.
Requirements
- High school diploma/GED with 12 years of Quality Control experience, or an associate’s degree with 10 years, bachelor’s degree with 5 years, master’s degree with 3 years, or a doctorate degree.
- Direct people-management experience or leadership experience directing teams, projects, programs, or resource allocation.
- Experience in a GMP-regulated Quality Control laboratory with the ability to work independently.
- Hands-on analytical testing experience in chemistry, bioassay, and/or microbiology.
- Knowledge of data integrity, GDP, GMP, 21 CFR Part 11, and preferably compendial methods such as USP–NF.
- Strong communication, organization, problem-solving, attention to detail, and ability to manage multiple priorities during off-shift hours.
Nice to have
- Scientific bachelor’s degree or equivalent experience.
- Previous experience as a QC shift lead, point of contact, or informal team lead.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Inclusive, collaborative, science-based work environment.
Hiring process
- Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
- Sponsorship for this role is not guaranteed.
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