Pfizer Quality Assurance Specialist in Carlisle, Pennsylvania

The Quality Assurance Specialist is accountable for activities involved in the evaluation and review of batch records, batch disposition, and review/approval of product/process related documents to determine if product (finished goods, intermediates, packaging and raw materials) specifications are met, ensuring that established sampling and statistical process control procedures are followed.

Identifying, tracking and reviewing deviations from established standards in the manufacturing and/or packaging of products, and initiating, reviewing and approving investigations and change control activities to ensure compliance with site policies and procedures.

Maintains routine programs and processes to ensure high quality product and compliance with current cGMPs and Pfizer Quality Standards. Must be familiar with all aspects of the manufacturing and quality operations.

Position will interact on a regular basis with Operations and Supply Chain departments. In addition to other QA personnel and Management.

Major job duties:

  • Perform review and disposition activities related to finished goods, intermediates, and packaging and raw materials.

  • Effectively communicate disposition status of materials and products to internal and external customers.

  • Prepare, issue and review Manufacturing Batch Records.

  • Track investigations, change controls, and action items as they relate to material disposition activities.

  • Author, review and approve GMP documents (i.e.: SOPs, CAS, MMI).

  • Perform initiation, maintenance and closure activities of Quality Assurance systems such as Deviations, Commitments, CAPAs, and Change Control to support QA operations and ensure compliance with SOPs and regulations.

  • Interpret generated data and communicate results to Quality Management.

  • Perform review and approval of documents in SAP and in Agile Manufacturing Production System (AMPS).

  • Track, maintain, report and present quality metrics.

  • Support site projects.

  • Support Product Quality Customer complaints investigation process.

  • Perform additional assignments as directed by the Quality Assurance Manager/Supervisor.

Qualifications:

Education:

  • Bachelor of Science degree or equivalent.

Experience:

  • 2- 4 years relevant Quality Assurance experience.

  • Strong attention to detail and organizational skills.

  • Ability to effectively prioritize and manage a varied workload is an essential function of this position.

  • Manufacturing environment experience, preferably in the nutraceuticals, pharmaceutical or medical device industry.

  • Clear understanding of cGMP concepts and requirements.

  • Must be able to read, write, speak, and understand fluent English.

  • Intermediate knowledge of MS Office and electronic inventory control systems (i.e, SAP, AMPs, etc.)

  • Ability to demonstrate accuracy and thoroughness while completing work in a timely manner.

  • Effective interpersonal and communication skills.

  • Follows instructions, policies, and procedures.

Physical/Mental requirements:

Office position with time spent in the production environment.

Lift banker boxes not to exceed 25 lbs.

Ability to perform data analysis.

Non-standard Work Schedule Requirements: This position is primarily on 1st Shift, 8am-4:30pm. Overtime work including evening and weekends may be required.

Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.

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.

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.

Other Job Details:

  • Last Date to Apply for Job: July 26, 2018

  • Eligible for Employee Referral Bonus - Yes(REQUIRED IF BEING OFFERED)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.