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3 дня назад

Senior Associate Quality Assurance (Biotech)

82 081 - 111 052$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Associate Quality Assurance (Biotech): Providing daily quality oversight for drug product manufacturing at a GMP facility with an accent on batch review, quality systems, documentation approval, and compliance assessment. Focus on supporting 24/7 clean-room production, evaluating deviations and compliance issues, and maintaining quality records through completion.

Location: Thousand Oaks, California, United States; onsite support in a 24/7 Grade 8 clean-room drug product filling facility

Salary: USD 82,081.95–111,052.05 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Provide daily Quality Assurance oversight for drug product manufacturing operations.
  • Support manufacturing-floor activities, including Grade 8 gowning, manual visual inspection, ASP/AQL performance, and QA oversight assessments.
  • Review electronic batches, electronic batch records, GMP documents, SOPs, forms, maintenance work orders, and job plans.
  • Support and approve minor deviations and evaluate compliance issues.
  • Provide recommendations and ensure quality records progress through completion.
  • Support 24/7 production through rotating day, swing, and graveyard shifts of 8–12 hours, including weekends.

Requirements

  • High school diploma or GED plus 4 years of GMP experience, or an associate degree plus 2 years of GMP experience, or a bachelor’s degree plus 6 months of GMP experience, or a master’s degree.
  • Experience following detailed SOPs, maintaining training, and applying good documentation practices in GMP operations.
  • Experience with quality systems and evaluating documentation and operations against company procedures.
  • Ability to work in a clean-room environment, meet gowning requirements, and support rotating shifts and 24/7 production.
  • Strong organization, communication, teamwork, independent working, and multitasking skills.

Nice to have

  • Bachelor’s degree in biochemistry, biology, chemistry, or a related science field.
  • Experience managing projects through completion and meeting timelines.
  • Leadership attributes and experience driving improvement initiatives.
  • Understanding and application of aseptic behaviors and principles.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • 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.

Hiring process

  • Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
  • Sponsorship for this role is not guaranteed.

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