Compliance Coordinator

Use Your Power for Purpose

Everything 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 Will You Achieve

You will be a member of Pfizers dedicated and highly effective Compliance team. You will be responsible for activities involved in developing and maintaining quality programs processes and procedures that ensure compliance with established standards and agency guidelines.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

In this role you will:

• Interfaces with site departments in the coordination of audit planning and post audit activities; including but not limited to fulfilling pre-requests scheduling staffing support of the inspection active participation in the inspection writing responses evaluation of robustness of responses and CAPAs received from departments and submitting responses to agency/ customer.

• Potential interactions and communications with the regulatory agencies/ customers.
• Participates in regulatory inspections assessments and customer audits as appropriate.
• Ability to support internal audits as needed
• Participates in the development and delivery of audit preparedness training and regulatory inspection preparedness training.
• Support of the Commitment Tracking Model of the CAPA Management system including Initiator Responsible Person and/or Approver of records.
• Evaluates applicable corrective and preventive action responses to the audit findings for adequacy and timeliness. Assesses and approves closure of CAPAs within the CAPA Management system as the QA Approver for audit gQTS records.
• Reports on weaknesses ineffective procedures policy exceptions and discrepancies and as needed recommends appropriate corrective actions.
• Actively participates in continuous improvement initiatives to align with business strategies.
• As needed leads or participates in self-audit preparation resolution of self-audit findings and liaises with auditing groups and audit stakeholders through all stages of the audits.
• Maintenance of the management of Quality Improvement Plans (QIP) for the site. This includes but not limited to prepares the QIP governance presentation for the site on a set frequency integrates continuous improvements of the QIP and lead CAPA Audit Commitment meetings.
• Lead or support of the Inspection Readiness Program. Prepares the Inspection Readiness presentations lead the Inspection Readiness meetings and responsible for maintenance of follow up actions to ensure the actions are executed in a timely manner.
• Lead or support of the Compendial Compliance Program.
• Lead or support of the Site Quality Review Team metrics. This includes but not limited to the gathering of site metrics and data compiling the presentations meeting minutes schedules etc.
• Support of the following: Site Master File Site Regulatory State License Program and other Compliance activities as they arise.
• Supports the preparation revision and implementation of relevant SOPs.
• Supports all compliance responsibilities.

Here Is What You Need (Minimum Requirements)

• Applicant must have High School Diploma (or Equivalent) with six (6) years of relevant experience.
• OR an Associates degree with four (4) years of experience;
• OR a Bachelors degree with two (2) years of experience.
• Minimum of 2 years of experience in one or more of the following:
  • Quality Engineering/Compliance/Regulatory Affairs/Quality Laboratories
  • Manufacturing / Technical experience in Pharmaceutical or GxP regulated environment
• Strong understanding of regulatory requirements and compliance standards.
• Excellent attention to detail and organizational skills.
• Demonstrated ability to work/ contribute to a team-based environment as a lead and a participant with strong interpersonal skills and demonstrated problem-solving skills.
• Proficiency in Microsoft Office Suite (Word Excel PowerPoint).
• Effective written and verbal communication skills.

Bonus Points If You Have:

• ASQ-CQA certification
• Demonstrated working knowledge and understanding of laboratory procedures sample processing / analysis and lab calculations
• Working knowledge of contemporary analytical techniques
• Knowledge of Good Manufacturing Practices also cGMP validation principles audit techniques and working knowledge of statistics
• Experience with audit processes and corrective action plans.
• Knowledge of drug/device product requirements

PHYSICAL/MENTAL REQUIREMENTS

• Prolonged sitting or standing
• Allow for flexibility in shifts to accommodate ad-hoc assignments on an as needed basis

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work extended hours especially during health authority inspections assessments and audits.
• Ability to support internal audits as needed
• Adherence to safe work practices and procedures by applying appropriate safety and PPE measures as needed

Work Location Assignment:On Premise

The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes 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 (). 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.

Quality Assurance and Control