Pfizer Sr Compliance Specialist in Brentwood, Missouri
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This position is responsible for ensuring overall QA Team compliance at either Westport or Brentwood with Pfizer Quality Standards, Regulatory Commitments, Internal and External Audit commitments, project improvements and corrective actions are completed within specified time frames. The position will lead investigations related to Quality Department deviations and assist the QA team in evaluation and analysis of data to support investigations or special projects. Other Quality Assurance tasks will be assigned as required.
The essential functions of the position may include, but are not limited to:
• Work with and support QA Sr. Manager on CAS Reports, Regulatory and Audit (Internal and External) commitments, CAPAs and other actions as needed.
• Work along with QA Team commitment owners and QA Sr. Manager on developing deliverables
• Retrieve, analyze, evaluate, summarize and tabulate data for informed reporting to the site and upper management.
• Update PBL metrics, Project Progress Report, and Commitment/CAPA status.
• Identify deficiencies and work along with the QA Team owner for the necessary corrective actions.
• Support site audits and regulatory inspections.
• Coordinate meetings, calls and meeting minutes as needed.
• Investigate and document QA related deviations.
• Perform other Quality Assurance functions as needed.
• Education: BS in Chemistry, Microbiology, Engineering or other science related discipline
• Experience: Minimum of seven years' experience GMP Pharmaceutical Manufacturing, experience in Quality Assurance preferred;
• Aseptic Operations preferred
• ASQ Quality Engineering or Black Belt certification preferred
• Ability to perform and understand data analysis and statistics
• Knowledge of FDA and international regulations
• Excellent verbal and written communication skills
• Computer literate - Microsoft Office
• Technical Skills - Excellent knowledge of manufacturing operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status.
• Oral Communication - Listens carefully and gets clarification. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-
• Team Work - Contributes to building a positive team spirit.
• Written Communication - Writes clear, accurate and concise technical and non-technical documents.
• Diversity - Shows respect and sensitivity for personal and cultural differences.
• Interpersonal - Interfaces with management and non-management employees in manufacturing, packaging, Inspection, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories
• Ethics - Works with integrity and ethically. Maintains confidentiality.
• Organizational Support - Supports organization's goals and values. Willing to work together to achieve a common goal.
• Adaptability - Able to deal with frequent change, delays, and/or unexpected events.
• Dependability - Completes tasks on time or notifies appropriate person of impending delays with an alternate course of action.
• Innovation - Meets challenges with resourcefulness.
• Judgment - Exhibits sound and accurate judgment.
• Professionalism - Treats others with respect and consideration regardless of their status or position.
• Quality - Produces analytical work of high quality. Looks for, and suggests ways to improve and promote quality.
• Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.
Pfizer 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.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.