30 days old

Associate Specialist QO

Pfizer
Rochester, MI 48307
**ROLE SUMMARY**

The Rochester Quality Assurance Specialist is responsible for providing quality assurance support to manufacturing operations. Most of the Quality Assurance Specialist's time will be spent on the manufacturing floor providing real time support and review of operational activities. This role will also be responsible for partnering with operations to perform detailed investigations into manufacturing deviations. The Quality Assurance role will also be responsible for performing batch record reviews and lot release activities.



**ROLE RESPONSIBILITIES**



+ Provide Quality oversight to manufacturing operations.

+ Support incoming material inspection and release and packaging statistical inspections.

+ Support robust investigation process for operations/facilities deviations including timely identification of root cause, CAPAs and closure of the deviation.

+ Perform lot release activities such as batch record review.

+ Independently writes and/or reviews SOPs, technical reports, project plans, etc.

+ Demonstrates complete knowledge of quality and manufacturing operations including both technical and compliance aspects.

+ Demonstrates understanding of current aseptic manufacturing best practices.

+ Supports implementation of quality assurance continuous improvement initiatives.

+ May also present/defend QAduring audits/inspections.



**QUALIFICATIONS**

**Education:** BA/BS required, or a MS in Chemistry, Biochemistry, Microbiology, or related science preferred.



**Experience:** Minimum 3 years of experience in a cGMP environment, with a strong working knowledge of a variety of quality systems and processes. Prior experience in a GMP quality team environment strongly preferred. The candidate must have demonstrated proficiency in organizational skills and must be able to balance multiple priorities. The candidate must have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review.



**Communication:** Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Ability to act decisively in real time and communicate/defend decisions with applicable areas of the organization.



**Reasoning Ability:** Strong analytical and problem-solving abilities.



**Technical:** Comprehensive understanding of cGMP guidelines outlined in CFR. Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements. Independently writes SOPs, technical reports, project plans, etc. Basic understanding of aseptic manufacturing highly desirable.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Must not be allergic to Penicillin



**OTHER JOB DETAILS**



+ **Last Date to Apply: May 8, 2020**

+ **Eligible for Employee Referral Bonus**



**\#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.



Quality Assurance and Control

Categories

Posted: 2020-04-28 Expires: 2020-05-28

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Associate Specialist QO

Pfizer
Rochester, MI 48307

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