
Aseptic Specialist
1 day ago
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:
- Lead and deliver Aseptic Excellence and Sterility Assurance Programs, whilst interfacing with global support teams.
- Partner with key stakeholders to provide direction and guidance on GMP Compliance matters relating to sterility assurance and monitor aseptic operations and compliance status
- Lead or participate in investigations and implement corrective actions
- Review and approve reports, risk assessment, procedures associated with sterility assurance
- Prepare for and participate in Site Internal Audits, Corporate Audits and BOHs Inspections, ensuring successful outcomes and timely implementation/closure of action plans.
- Contribute to moderately complex projects, manage time effectively, and develop short-term work plans.
- Drive a proactive quality culture across the Company to deliver products Right First Time (RFT).
Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- Demonstrated experience working in a cGMP (current Good Manufacturing Practices) environment with strong understanding of Quality Systems functions
- Experience in preparing and participating in audits and inspections
- Self-motivated with a proven ability to deliver results in a team environment
- Excellent technical writing, communication, and presentation skills
- Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
Bonus Points If You Have (Preferred Requirements)
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
- Ability to adapt to changing priorities and manage multiple tasks simultaneously
- Experience in mentoring and training colleagues
Work Location Assignment: Hybrid
At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:
- Paid parental leave- Access to Health & Wellness apps- Career Growth Experiences program- Recognition & rewards program- Paid volunteer days- Life Insurance Benefits- Pfizer Learning Academy access to top content providers- Access to flu vaccines & skin checks- Options to purchase additional leave- Salary packaging & novated lease options
Quality Assurance and Control
LI-PFE