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About the Role
The QA Specialist, Aseptic Manufacturing Oversight ensures compliance with procedures and regulations, providing real-time quality oversight in aseptic manufacturing areas to meet GMP, regulatory, and site quality standards. This role supports immediate issue identification, decision support, and promotes a strong quality culture while partnering with operations and quality staff to achieve production goals.
Responsibilities
- Perform in person APA oversight, requiring gown qualification maintenance.
- Perform APA video review, including gowning, cleaning, set-up, filling, and environmental monitoring, live or retrospectively.
- Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
- Identify and escalate major and critical observations from video review.
- Evaluate and categorize observations from video review per procedure.
- Document video review performance and observations per procedure.
- Assist with video review of Environmental Monitoring and Personnel Monitoring events.
- Assist with trending and tracking of video review observations for CAPA development.
- Assist with development and delivery of training related to aseptic manufacturing behaviors and practices.
- Review and approve deviation investigations and CAPAs.
- Actively participate in cross-functional project teams.
- Collaborate with colleagues to achieve desired outcomes.
- Make recommendations for improvements to procedures and processes.
- Stay informed about current good industry practices and recommend improvements.
- Perform all duties in accordance with business principles, directives, SOPs, policies, and regulatory guidelines.
- Communicate with tact and consideration for constructive feedback.
- Perform any other tasks/duties as assigned by management.
Requirements
- Demonstrate ability to become and remain gown qualified for APA presence.
- Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
- Demonstrate ability to perform detail-oriented work with a high degree of accuracy.
- Effective time management and collaboration skills.
- Strong organizational skills and planning skills.
- Must work effectively within teams.
- Ability to resolve conflicts and disagreements on regulatory compliance issues.
Skills
- Excellent verbal, written, and interpersonal communication skills.
Location
- Onsite
Work Type
- Full-time
Experience Level
- 2-5 years experience within the pharmaceutical industry including aseptic manufacturing
Education Level
- Bachelor’s degree in a Science or Engineering field
- Equivalent years of experience to be considered
Salary/Compensations
- $70,100 - $80,000
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
- Wide range of other benefits
About the Company
- American Regent celebrates diversity and is committed to creating an inclusive environment for all employees.
- American Regent endeavors to make https://careers.americanregent.com/ accessible to any and all users.
Equal Opportunity
- We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
- Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf