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Mgr/TL Quality Assurance


Franklin, OH 45005
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Job Details


+ Among other responsibilities, the QA Manager develops quality policies and procedures to assure process, product, material, components quality. Activities include: disposition of in-process and finished product, management of the investigation and CAPA system including product complaints, and the administration of master batch records (MBRs), specifications and supplementary documents


+ Accountable for activities involved in the evaluation and review of executed batch records and testing results, product disposition, and review/approval of product/process related documents to determine if product specifications and Pfizer policies are met

+ Accountable for investigation of quality issues, including customer complaints. Ensures the compliance with regulations for the quality of the investigations, the identification of the root cause, the identification of the appropriate correctives and preventative actions, and the product impact and disposition

+ Accountable for activities involved in the revision, approval and control of master batch records (MBRs), product specifications and other supplementary documents associated to the manufacture, testing and disposition of product


+ BA/BS, or MS in Chemistry, Biochemistry, Microbiology or related science with a minimum of 10 years related experience in Quality Operations supporting pharmaceutical processes

+ Qualified candidate must be detail oriented and able to make sound decisions

+ Strong working knowledge of cGMP with high productivity and ability to multi-task coupled with a low error rate

+ Must have demonstrated proficiency in deviation investigations, change management and regulatory inspections

+ Must have a strong working knowledge of company and regulatory requirements (e.g. ICH)

+ The successful candidate must also have demonstrated ability to complete and manage projects independently

+ The position also requires strong interpersonal, supervisory, oral, and written communications skills and computer literacy


+ While performing the duties of this job, the employee is exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus

+ Position requires regular onsite attendance, this position cannot be performed on a remote / telecommute basis


+ Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements

+ Must have the ability to work effectively under and manage to strict production, time and performance deadlines

+ Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays

+ Minimal travel requirements are expected

**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.

**S** **unshine 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.

+ **Last Date to Apply for Job: 1/31/2018**

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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