Location
Sanford, 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.
Role Summary The position will be responsible for completing investigations (ER's and QAR's) in the site investigations electronic system (Veeva Vault) as part of the centralized investigations team in the Technical Operations department at the Sanford site. The position leads investigations as the responsible person, coordinates CAPA, and drives to on time closure of investigations.
The candidate should be detail-oriented, able to execute work independently with strong organizational and communication skills, able to work with various groups across the organization, and be able to utilize Method 1, Pfizer Human Performance, and operational excellence tools and techniques.
In addition, knowledge of other electronic systems used at the site including PDOCs, LIMS, SAP, PLS, EAMS, MS Word, MS Powerpoint and MS Excel is required as part of the job.
Role Responsibilities Responsibilities include the following:
- Perform investigations for manufacturing, engineering and maintenance, QA, QC, supply chain, and technical operations related deviations including:
- Utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) and Pfizer Human Performance tools to perform root cause analysis during investigations
- Interacting and coordinating with appropriate personnel including internal departments, outside vendors, bacterial/viral development QA, regulatory (US/Japan/EU/China), and Qualified Persons during the investigation process
- Facilitating cross-functional and cross-site team meetings and reviews to resolve investigation issues. Ability to identify issues, present complex problems with possible solutions, and actively takes leadership role to resolve issues
- Assessing the impact of events on products, equipment, or processes, communicating with management for all discrepancies that may impact product, and recommending disposition
- Proposing solutions to identified problems, determining corrective actions and continuous improvements, and assigning commitments to facilitate implementation of solutions
- Tracking, trending, and evaluating previous events and assessing CAPA effectiveness and impact to current investigation
- Drafting written investigations to assure clear, concise summaries, product impact assessments, and commitments
- Collaborating with QA to close investigations and to assign commitments for CAPAs
- Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
- Support regulatory and internal audits through the preparation, defense and interaction with auditors for requested investigations
- Strong understanding of cGMP, Data Integrity and ALCOA principles.
- Execution and management of multiple initiatives at the same time and good communication skills to keep customers, peers, and area management up-to-date with progress of all such efforts
Qualifications Must have: - High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associates degree in Statistics, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline with 6 years of experience OR a Bachelor's degree in Statistics, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline with at least 3 years of experience OR Masters with more than 1 year of experience.
- Experience required in Manufacturing, Quality and/or Engineering
Nice-to-Have: - Direct knowledge and experience in 6 Sigma and Lean methodologies and relevant experience in a biopharmaceutical or pharmaceutical cGMP environment is required.
- Experience with completing investigations within a quality tracking system is required.
- Experience with FDA and EU licensing and inspection is preferred.
- Experience with project management is desired.
- Experience using Documentum systems (such as PDOCS), laboratory information management systems (such as LIMS), learning management systems (such as Plateau, PLS, P2L), inventory management systems (such as SAP), and asset management systems (such as EAMS) are highly desired.
- Proficiency with MS Word, MS Powerpoint and MS Excel are required.
Physical / Mental requirements - Position requirements are typical for an office-based work environment with some shop floor exposure.
Non-Standard work schedule, travel or environment requirements - Schedule is primarily day shift (M-F, 8 hrs) but may require off-shift work on occasions.
- Overtime may periodically be required.
- The position may require working on the floor in manufacturing, laboratory, or utility areas at times which will require a focus on safety.
- Aseptic gowning could be required.
Other job details - Last day to apply: September 7th, 2023
- Employee Referral Bonus eligible
- Relocation support available
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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