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Quality Assurance Inspector 2


St. Louis, MO
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Job Details


First 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. Operates some technical equipment with training.


Essential Duties and Responsibilities of this position include but are not limited to:

Performs physical testing of components with supervision from a senior inspector. Reports any problems found during inspection to the Senior Inspector. Samples and inspects components, drug product containers, packaging and labeling according to approved written material specifications, engineering drawings, artwork, and specimen labeling. Samples and inspects product operations for each new control per product line and initial line inspections to assure the identity, quality, and trace ability of incoming product materials according to current SOPs. Follows GMP documentation practices in manufacturing and packaging batch records. Accompanies Inspector III or IV in performing room inspections, in-process checks, and verifications for various production areas. Accompanies Inspector III or IV in performing sampling for laboratory control testing, stability testing, and other special purposes. Performs checks on packaging lines (example - container fill volumes and quantity) and trains to inspect finished product for defects in assembly and variations in package or product quality. 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 Recognizes and reports problems and adverse quality events to Senior Inspector.


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

Knowledge Necessary to Perform the Job:

+ Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine materials disposition.


**Work Environment and** **Physical Demands:**

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 accommodations 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; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this job include close vision, color vision, and the ability to adjust and focus. Must achieve a score of 8 or better for near vision (14") with both eyes, using the Titmus II vision tester or 20/25 on a nearpoint Snellen acuity card at 16". Acceptable visual acuity is a Snellen fraction of 20/25 or greater. They must have normal color vision by Ishihara screening.

Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

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.

**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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

**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:** 15 December, 2015

This is a Pfizer Non-Exempt Role

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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