6 days old

Quality Control Analyst 2

Pfizer
St Louis, MO 63103
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**ROLE SUMMARY**

Second level position with training in statistical sampling and inspection of incoming materials, filled products, packaged products and processes for conformance to approved written specifications, SOPs, cGMPs, and FDA regulations. Requires training in physical testing. Is able to perform sampling and inspection without constant supervision.



**ROLE RESPONSIBILITIES**



+ Performs physical testing of components or finished product with supervision from laboratory management.

+ Reports any problems found during inspection to the laboratory management.

+ Samples and inspects components, drug product containers, packaging and labeling according to approved written material specifications, artwork, and specimen labeling.

+ Sampling and inspects product operations for each new control per approved product specifications to assure the identity, quality, and trace ability of incoming product materials according to current SOPs.

+ Follows GMP documentation practices in test reports, manufacturing and packaging batch records.

+ Understands and recognizes product status such as Approved, Hold, Rejected, etc.

+ Reviews manufacturing and packaging batch records.

+ Understands Good Manufacturing Practice regulations

+ Understands and utilizes ANSI sampling plans.



**BASIC QUALIFICATIONS**



+ HS/GED with three years general work experience and at least one year related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience.

+ Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine material's disposition.

+ This is a second shift position.



**PREFERRED QUALIFICATIONS**



+ Bachelor's degree in scientific discipline.

+ 6+ years' experience

+ Certification in assigned area, if applicable

+ Ability and knowledge to make quick calls during inspection and demonstrates the ability to recognize situations that may halt production

+ Ability to simultaneously multi-task across capabilities and functions and handle competing priorities and requirements



**PHYSICAL/MENTAL REQUIREMENTS**

The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accomodations may be made to enable individuals with disabilities to perform the essential functions.



While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.



T he job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last Date to Apply for Job: October 22, 2020

Eligible for Employee Referral Program



**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
Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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Quality Control Analyst 2

Pfizer
St Louis, MO 63103

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