3 дня назад
Senior Associate Quality Assurance (Biotech)
82 081 - 111 052$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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