Quality Compliance Coach Lead
Location
Rocky Mount, NC | United States
Job description
Why Patients Need You
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 You Will Achieve You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Team lead, you will be involved in leading work teams within a division. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
The primary function of the Quality Compliance Coach Lead is to manage and coordinate the Quality Compliance Coaches to monitor the areas for best practices/techniques within the R1/R2/R3 SVP filling manufacturing areas. The Lead will coordinate between the operations and manage the coaches observation sessions for the production schedule to ensure that coverage is maintained throughout the process. This candidate will also be the point of contact for recovery if there is loss of environmental control to approve the recovery process. The candidate will perform routine observations of the aseptic and TS operation to ensure compliance in alignment with site SOPs, best practices, and regulations. In addition, the Lead must be able to train new and existing colleagues on aseptic principles and coach them on expectations for sterile manufacturing.
This is a 12-hour second shift position, on the 2-2-3 schedule working 1500-0300; this will give the Quality Compliance Coach Lead the ability to interact with day shift and night shift coaches for consistency across the coaching program.
How You Will Achieve It - Lead and work to develop a team of Quality Compliance Specialists ensuring training on SOPs, compliance and aseptic principles for sterile manufacturing
- Coordinate and manage observation sessions for the SVP filling lines.
- Review aseptic coach training and site procedures for improvement opportunities.
- Assist with investigations within the aseptic areas.
- Review and filing of completed aseptic observations
- Accumulates key metrics and report out to site Management teams, including gowning and aseptic technique observation. Complete quarterly reports for the aseptic coaching program.
- Perform observation sessions and coaching, as needed, of SVP Filling operations. Perform observation sessions of sanitation, aseptic techniques, clean room behaviors, stopper offloading, and aseptic gowning activities as needed to provide sufficient coverage.
- Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
- Provide oversight support to aseptic process simulations (media fills), smoke studies, and hypercare for new sterile manufacturing processes when needed.
Qualifications Must-Have - Bachelor's Degree
- 3+ years' experience
- Experience in Production Operations, Quality Control, Quality Assurance & Compliance.
- Advanced analytical skills will be required to make competent decisions based on a review of analytical data.
- Demonstrated leadership qualities with trouble shooting abilities in manufacturing area.
- Quality operations technical knowledge.
- Strong people management experience.
- Effective communications skills required, both written and verbal.
- Requires strong interpersonal skills and the ability to handle multiple projects.
Nice-to-Have - Master's degree
- Sterile manufacturing on the floor pharmaceutical experience within quality organization.
- Experience using data analysis computer tools and statistical analysis.
PHYSICAL/MENTAL REQUIREMENTS Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.
Must be able to consistently aseptic gown.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must be able to work on weekend, off shifts and holiday as business demands.
Work Location Assignment: On Premise
The 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 Act Pfizer 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 Eligibility 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 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
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