**ROLE SUMMARY:**

The primary function of the Quality Compliance Specialist is to monitor, teach, and enforce best and proper aseptic practices/techniques within the R1/R2/R3 SVP filling manufacturing areas. The candidate will perform routine monitoring duties of the aseptic and TS operation to ensure compliance in alignment with site SOPs and regulations. In addition, the candidate must be able to train new and existing colleagues on aseptic principles and coach them on expectation for sterile manufacturing.

**ROLE RESPONSIBILITIES:**

+ Perform necessary assessments of Aseptic or Terminal Sterilized SVP Filling operation and update necessary documents.

+ Accumulates key metrics for presentation to Management teams, including gowning and aseptic technique observation.

+ Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.

+ Perform audits of sanitation, aseptic techniques, clean room behaviors, equipment cleaning/loading activities, and gowning

+ Write investigations and implement CAPAs

+ Generate change controls for procedure updates

+ Provide support to aseptic process simulations (media fills), smoke studies, and hypercare for new aseptic processes when implemented.

+ Provides support to other investigations on site to help to identify root cause(s).

**BASIC QUALIFICATIONS:**

**Must-Have**

+ Requires Bachelor’s Degree in a technical, science or engineering field

+ Requires 3+ years knowledge/experience in aseptic technique/pharmaceutical industry.

+ Requires strong oral, written, communication, presentation and interpersonal skills.

+ Requires thorough knowledge of GMP’s and ability to handle multiple projects.

**PREFERRED QUALIFICATIONS:**

+ Pharmaceutical manufacturing experience

**PHYSICAL/MENTAL REQUIREMENTS**

Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.

Must be able to consistently aseptically gown.

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

rotating – Night shift from 7pm to 7am, 2/2/3 schedule. Must be able to work on weekend, off shifts and holiday as business demands.

**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: April 14, 2021**

+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES

+ #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.

Manufacturing

#LI-PFE

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