Associate QA Specialist
Zoetis

Job Info

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Work with internal manufacturing colleagues as a cross functional member and approver of Zoetis investigations. Participates in production lab walk through audits prior/post construction projects as well as on-going maintenance activities requiring Quality oversite. Provides manufacturing floor support as needed to maintain compliance with local policies and procedures. Review and approval of Environmental monitoring data and reports. Participates in/ supports regulatory inspections as well as follow up action items. Performs product related system dispositions as necessary based on local site procedures. Perform batch record reviews and review of other records relating to processing of components, materials and finished veterinary biological for comparison with approved specifications and regulatory requirements, as necessary to support timely release of product.

Position Responsibilities:

•Inspection of materials to internal specification requirements and regulatory as required

•Support of the specifications

•Disposition of the incoming materials as required

•Authoring of SOPs associated with the areas

•Inventory and cycle counts

•Labeling artwork approvals

•Change controls pertaining to raw materials

•Vendor investigations pertaining to raw materials •Ensures cGMP compliance within the site's quality systems

•Interpretation and enforcement of 9CFR, EU and other regulatory guidelines

•Handling of customer complaints

•Support regulatory agency, customer and internal audits

•Review and approval of action items / commitment tracking items

•Review and approval of interim reports

•Assist in performing internal audits

•Assist in the review and assessment of Zoetis Quality Standards (ZQS) •Perform assigned batch record reviews

•Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.

•Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures

•Audit manufacturing processes for compliance against approved regulatory licenses. •Documentation review

•Data collection for site Metrics

•Support role for all areas of Quality

•Database review for support of release •Actively support, review and approve of all manufacturing/environmental/ GMP deviations as well as related items (action items, commitments tracking, etc) related to manufacture of veterinary biological products at the Charles City, Iowa facility.

•Conduct walk through audits as part of the paint and patch process as well as ongoing construction activities being conducted at the site.

•Performs product related system dispositions based on local site procedures.

•Participates on in the Change Management process either as a team member or change agent.

•Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.

Education and Experience:

Associate: BA/BS with 0-2 years of experience OR Minimum of 6 years relevant experience. Specialist: BA/BS with 2-4 years of experience OR Minimum of 8 years relevant experience.

• Training in CAPA, Analytical Problem Solving and Root Cause Analysis preferred. Basic problem-solving skills.
• Excellent verbal and written communication skills, fluent in English.
• Proficient with the following software programs: SAP, Word, Excel, and PowerPoint .
• Excellent organizational skills and strong ability to multi-task.
• Willingness to positively embrace change and flexibility in adjusting to changing priorities.
• Strong attention to detail, ability to work well independently and as part of a team, and to work effectively with people at all levels within the organization.
• Travel may be required.

Physical Requirements

• Must be able to walk or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 5 to 25 lbs
• Regular reaching, bending, stooping, and twisting
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

This job has expired.