1+ months

Associate Specialist Quality Operations

Pfizer
Kalamazoo, MI 49007
**ROLE SUMMARY**

This posting is for a position on the DP QA Batch Record Review team supporting the entire drug product operation (injectables, LSS, powders, Bio-Ops, Inj. Packaging, Inspection, etc.) with the primary responsibility of reviewing and approving master records (batch records) to ensure that the information and documentation conforms to Pfizer policy and cGMP's. Additional responsibilities will include various lot release functions, deviation support, and audit support (SSA). This role is part of the greater DP QA team, whose responsibility is to ensure timely release of conforming Drug Product, upholding cGMPs as well as timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).



**ROLE RESPONSIBILITIES**

Primary Responsibilities Include:



+ Review and approve Drug Product manufacturing records to ensure that the information and documentation conforms to Pfizer policy and cGMP's

+ Communicates errors to appropriate parties and facilitates corrections

+ Works with Operations to correct and reduce errors through effective communication and continuous improvement initiatives

+ Tracks and communicates status of tickets to key stakeholders

+ Generates COCs for certain Stopper and Solution EDPs and provides to end customer as appropriate

+ System Interface (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc...)

+ Audit support SME as needed

+ Drive continuous improvement initiatives to support the overall attainment goal

+ Supports IMEX initiatives within the team



Additional Responsibilities Include:



+ Conforming Lot Release for Finished Products (Level 1)

+ Audit (SSA) Involvement

+ Deviation Support

+ Event Reports

+ QARs related to Ticket Review

+ Ticket Comments

+ Floor Support

+ Change Control Review

+ Maintains Quality Systems and ensures that products conform to regulatory, compendial and Pfizer Quality Standards.

+ Proven written and oral communication skills based on good Pfizer leader behaviors.



**BASIC QUALIFICATIONS**



+ Education: BS in Chemistry, Biology, Microbiology, Engineering or other science related (STEM) discipline required

+ Experience: No minimum experience required; however, 2 years of experience preferred. At least 1 year of experience at a manufacturing site with GMP document review preferred.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Office position with time in the production environment.

+ Consistently produces quality work.

+ Must be able to work in a team environment within own team and interdepartmental teams.

+ Must work under short timelines while maintaining quality work.

+ Must have strong written and oral communication skills.



+ **Last Date to Apply: May 20t h, 2020**

+ **Eligible for Employee Referral Bonus**



**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: 2020-05-07 Expires: 2020-07-08

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Associate Specialist Quality Operations

Pfizer
Kalamazoo, MI 49007

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