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8 дней назад

Manager Quality Control I - Nights (Biotech)

11 406 320 - 15 432 080$
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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