Quality Systems Specialist
ROLE SUMMARY
Ensures that manufacturing operations conform to established standards and specifications. Main functions include investigation and root cause analysis for manufacturing incident reports, deviations, and customer complaints. Assists in the formation and implementation of Corrective And Preventative Actions (CAPAs). Participates in multi-departmental meetings. Assists in batch record review, evaluation, and release of finished products, raw materials, and packaging components.
ROLE RESPONSIBILITIES
- Proficient in the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations and to provide a good understanding of processes when conducting investigations.
- Initiates, writes, reviews, edits, and drives investigations, interim reports, and commitments to closure to meet established timelines using the Trackwise/QTS system
- Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors during manufacturing and packaging operations.
- Participates in understanding failures (FMEA) and resulting CAPAs through investigations, root cause analysis, and incident reports.
- Maintains proficiency in performance of all applicable Manufacturing and Quality
- Standard Operating Procedures (SOPs) for this area.
- Assists in review and editing of SOPs and Master Batch Records.
- Reviews Batch Records for compliance to SOPs and determination of batch acceptability.
- Participates in, or responds to, quality audits when applicable to assure conformance with regulatory and internal requirements.
- Off shift and weekend availability sometimes required.
- Other duties, responsibilities and qualifications may be required and/or assigned as necessary.
BASIC QUALIFICATIONS
- Bachelor's degree in a technical field (Biology, Chemistry, Engineering, or Pharmacy)
- Experience in API manufacture and technical knowledge of production systems associated with API manufacture
PREFERRED QUALIFICATIONS
- 1-2 years experience in conducting and documenting manufacturing incident or customer complaint investigations.
- Training in Method 1, Pfizer Human Performance (PHP), and Pfizer Technical Writing programs.
- Familiarity with the use and functionality of Trackwise.
- Last Date to Apply: May 8th, 2020
#LI-PFE
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.