Quality Operations Professional
ROLE SUMMARYQuality Operations Professionals (QOP) provide Quality Assurance on the factory floor team, supporting deviations and providing real time quality impact support in McPherson Drug Product Operations. The colleague will need to effectively work and communicate with key stakeholders/peers to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions.
- Independently provide Real Time Quality impact assessments and decisions on Drug Product issues as needed:
- Ability to handle complex and detailed situations
- Accurately assess consequences of decisions
- Accurately assess potential Regulatory impacts on a Global basis
- Immediately escalate issues with potential market or stability impact
- Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.
- Participates in QAR Gembas with customers and peers
- After initial assessment of QARs and ERs, successfully transitions remainder of investigation to others to complete investigation write up as needed
- Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary
- Utilize tools such as Method 1 and Pfizer Human Performance in the course of the investigations
- Participate in QRM assessments that gain approval through Site and Area QO Management
- Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc… as appropriate
- Propose and implement improvements in the Deviation and/or Floor Support operations
- Independently assess a wide range of Change Control activities to determine potential Quality and Operational GMP impacts
- SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns
- Participates in internal GMP audits
- Effectively communicate complex technical issues to all levels of Management (including outside of Quality)
- Actively demonstrate Pfizer leader behaviors.
- May require A/B 12-hour shift representation on days or nights.
- Bachelor’s degree in Engineering, Business or Science with a minimum of 2+ years of experience and 1+ years demonstrated leadership capability preferably in a pharmaceutical and/or manufacturing environment.
- Able to lead by example, work in a team environment or independently with minimal guidance.
- Demonstrated desire to understand how things work and get to true root cause.
- Strong sense of ownership, Collaborative/Active Listener
- Able to effectively manage high pressure situations and work under short timelines. Able to focus on task at hand regardless of circumstances while maintaining quality work.
- Proven ability to communicate effectively verbal and in written form, including the presentation of data.
- Demonstrated proficiency in Microsoft Office programs, including Word, Excel, Outlook, MS Project or equivalent.
- Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or other science related discipline.
- Preferred experience writing and managing deviations.
- Previous pharma experience with a basic understanding of floor level pharmaceutical manufacturing.
Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.
May be required to aseptically gown.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
1st and 2nd shifts are available. Schedules include: 1st shift: 6 am – 6 pm on a 3/2/2 schedule or 2nd shift: 6 pm -6 am on a 3/2/2 schedule
Position may require some weekend and off shift presence as business needs dictate. Successful candidate may be required to complete various levels of gowning certification in order to enter and support manufacturing areas.
Other Job Details:
- Last Date to Apply for Job: 8/16/21
- Eligible for Employee Referral Bonus
- Eligible for Relocation Package