7 часов назад
Quality Compliance Specialist
68 600 - 114 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Compliance Specialist (Aseptic Pharmaceutical Manufacturing): Providing quality oversight for aseptic and terminally sterilized manufacturing operations with an accent on cGMP compliance, aseptic practices, and real-time event oversight. Focus on supporting media fills and smoke studies, maintaining inspection readiness, escalating deviations, and driving continuous improvement on the manufacturing floor.
Location: On premise in Rocky Mount, North Carolina, United States. Work schedule is 6 a.m. to 6 p.m. on a 2/2/3 rotation, including weekends, off shifts, and holidays as required. Permanent U.S. work authorization is required; visa sponsorship is not available.
Annual base salary: $68,600–$114,300, plus eligibility for a 7.5% bonus target.
Company
operates pharmaceutical manufacturing facilities producing medicines for patients worldwide.
What you will do
- Provide quality oversight in aseptic and terminally sterilized manufacturing areas.
- Enforce best aseptic practices through the Aseptic Observation Program.
- Support media fills, smoke studies, and hypercare for newly implemented aseptic processes.
- Provide real-time quality oversight and approvals during planned and unplanned events, process simulations, and environmental control deviations.
- Conduct GMP and inspection-readiness walkthroughs to maintain a compliant state.
- Drive continuous improvement projects and meet Aseptic Observation Program metrics.
Requirements
- Bachelor’s degree in a technical, science, or engineering discipline with 0+ years of experience; alternatively, an associate’s degree with 4 years of experience or a high school diploma with 6 years of relevant experience.
- Shop-floor experience in an aseptic manufacturing facility.
- Thorough knowledge of GMP requirements and the ability to manage multiple projects.
- Strong oral, written, communication, presentation, and interpersonal skills.
- Ability to remain focused under stress, identify and escalate issues promptly, and coach operators.
- 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
- Pharmaceutical manufacturing experience.
- Experience with isolator or RABS aseptic manufacturing.
Culture & 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.
- Medical, prescription drug, dental, and vision coverage.
- Relocation assistance may be available based on business needs and eligibility.
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