Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveYou will be a member of Pfizer's dedicated and highly effective quality assurance team. You will be responsible for supervising a specific shift to ensure that all manufacturing and packaging operations are operating within a state of Current Good Manufacturing Practices (cGMP) compliance. This individual will supervise and coordinate the quality functions within manufacturing with guided oversite and will be responsible for providing direction to colleagues.As a Manufacturing Quality Assurance Supervisor, you will quickly escalate quality-related issues to ensure that sufficient resources are applied to correctly investigate, document, and lead corrective actions.Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them.How You Will Achieve It- Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.- Implement process improvements with a focus on quality processes.- Provide input and decision making for quality on the shop floor with regard to manufacturing and deviations. Provide corrective action as necessary.- Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.- Provide daily supervision of Manufacturing Quality (MQ) colleagues and Quality Assurance (QA) Specialists (where applicable) working on a specific shift.- Assure that the appropriate resources are utilized on a specific shift as they relate to Corrective Action/Preventative Action (CAPAs), root cause analysis, preventive actions, trending results and corrective actions, in accordance with facility standards and cGMP compliance.- Direct manufacturing staff to uphold quality and determine when manufacturing lines need to be shut down to investigate production issues.- Work with the MQ Manager to ensure that all manufacturing and control procedures and specifications are followed as they relate to production, processes and equipment.- Create, review and approve cGMP audit reports.- Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMPs.- Create, review and approve deviations.- Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently. Escalate as necessary.- Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.- Participate in Yellow/Green/Black belt projects, Right First Time (RFT) Improvement projects, CAPA Effectiveness, etc. as appropriate.- Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.- Help to define appropriate action plans for improvement and follow-up and communicate action closures.- Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.QualificationsMust-Have
Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience;
OR an Associate's degree with six years of experience;OR a Bachelor's degree with at least three years of experience;OR a Master's degree with more than one year of experience.
Experiencein a compliance driven environment with regulatory body experience
Leadership (direct or indirect), coaching, supervisory experience
Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative
Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment
Effective communications skills required, both written and verbal.
Requires strong interpersonal skills and the ability to handle multiple projects
Nice-to-Have
Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products
Working knowledge of environmental monitoring, aseptic manufacturing in a clean room environment desirable
Understanding of process validation requirements
Experience of writing and managing deviations
Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
PHYSICAL/MENTAL REQUIREMENTS
Stand up for 8 to 10 hours
Sit up for 2 to 4 hours
Occasionally lift a maximum of 20 pounds 3 times per shift
Walking and climbing stairs
Work around and close to moving equipment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
12-Hr Day Shift (7a - 7p) on a rotating 2 - 2 - 3 schedule
May be required to work outside of scheduled shift to support business needs
Ability to gown aseptically for entry into the Aseptic core areas.
Ability to follow area specific gowning requirements for entry into the Terminally Sterilized areas and/or other classified solutions/filling areas.
Ability to work off-shifts and/or weekends as required.
Work Location Assignment:On PremiseJob Details: Last Date to Apply for Job: March 1st, 2024 Eligible for Employee Referral Bonus: Yes Schedule: Rotating-7am-7pmThe annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.Quality Assurance and Control#LI-PFE
