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Quality Assurance Specialist


Rochester, MI
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Job Details


The Rochester Quality Assurance Specialist is responsible for providing quality assurance support to manufacturing operations. A majority 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. This role may also require weekend work and some movement between shifts to support manufacturing operations as required.


+ Provide Quality oversight to manufacturing operations

+ Support Incoming material inspection and release

+ Supplier Quality Oversight

+ Support robust investigation into manufacturing deviations and facilitates timely identification of root cause 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 QA Quality Systems during audits/inspections.

+ This role may also require weekend work and some movement between shifts to support manufacturing operations as required.


**Education:** BA/BS, or MS in Chemistry, Biochemistry, Microbiology, or related science preferred with a minimum of 3 years related experience in Quality Operations.

**Experience:** Minimum experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems and processes. Prior experience in a people management role strongly preferred. The candidate must have demonstrated proficiency in organizational and project management 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.

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

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


Quality Operations Laboratory, Microbiological laboratory, Maintenance and Engineering, Quality Assurance, Warehouse, Validation, Manufacturing and Packaging.

**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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees

**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

**Additional Offer Details:**

+ **This job is Pfizer/Exempt/US/Grade: 004**

+ **Must not have a Penicillin allergy.**

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