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QA Specialist III (12 Hour Nights)


Austin, TX 78728
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Job Details


The QA Specialist is the primary contact for quality on the production floor. This role will monitor production processes for compliance to cGMP standards. He/She will perform and document the appropriate testing and inspection results in order to support product release.


Must verify critical product labeling information such as lot and list number, expiration date, product description, and manufacturing date (if applicable).

Must obtain a representative number of samples from the production line for visual inspection. Based on the product requirements, the samples may also require physical testing.

Must obtain samples that are required for long term storage for stability testing and annual retention inspection.

Must execute functional testing, physical testing, and product inspections when required per an approved procedure.

Must adhere to all safety and health practices and procedures.

Must be certified as a controlled drug agent (CDA).

Candidate must be able to act with ownership in their areas of responsibility.

Candidate should be able be proactive with preventing delays and/or downtime of equipment.

Ensure adherence to all plant safety rules in the area of responsibility.

Candidate must perform other related assignments and duties as required and assigned.


Must have a high school diploma with a minimum of 1+ years of related experience in an FDA regulated industry (preferably in quality assurance or quality control) with knowledge to provide guidance on quality related concerns. A Bioworks Program certificate may be used in the place of the work experience.

Must possess the basic knowledge of cGMPs and FDA requirements and computer skills.

Must have excellent organizational, interpersonal and communication skills (oral and written).

Must have a proven ability to work with minimum supervision.


+ May require lifting up to 35 lbs, sitting, standing for periods of up to 90 minutes, walking, bending for extended periods of time, and performance of repetitive motions for up to 60 minutes.

+ Must also be able to perform mathematical calculations and some data analysis.


Weekend and overtime work is required to meet the 12 hour shift schedule. The position is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards. Travel for this position is minimal.

**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.

+ **Last Date to Apply for Job: February 27, 2018**

+ Eligible for Relocation Package

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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