Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Lincoln, Nebraska
The Biological Operations - Associate QA Compliance Specialist is accountable for ensuring cGMP compliance within the site s Biological Operations and is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives. Primary responsibilities include: Initial transfer of new monoclonal antibody (MAb) biological therapeutic products, MAb product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site s compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of the MAb manufacturing within Zoetis Lincoln Biological Operations.
Taking a leadership role in the Quality Unit, working with internal and external groups, independently prioritizing areas of quality concern and addressing with limited manager intervention. Ability to organize resources and address complex quality decisions independently. Communicate effectively and decisively with manufacturing team members as well as members of site management.
The Biological Operations - Senior QA Specialist will also interface directly with regulatory agency, customer and internal auditors, provide support for market action activities and will assist in the identification and communication site and department metrics.
* Provide QA support for product process validation activities for MAb manufacturing
* Provide QA support for MAb product registrations and compliance
* Ensures cGMP compliance within the Biological Operations systems
* Interpretation and enforcement of FDA, USDA, EU and other regulatory guidelines
* Provides guidance and support within cGMP systems for site colleagues
* Support regulatory agency, customer and internal audits
* Review and approval of action items / commitment tracking items
* Review and approval of investigation and interim reports
* Support market action activities
* Perform internal audits (external audits as necessary)
* Batch record review, intermediate product release
* Participation in change management activities
* Assist in the review and assessment of Zoetis Quality Standards (ZQS)
* Collection and communication of site and department metrics
* Maintain department Standard Operating Procedures (SOPs)
* Other responsibilities as assigned
EDUCATION AND EXPERIENCE
B.A. or B.S. in Sciences or related field and at least 5 years of relevant experience. M.S. degree is preferred.
TECHNICAL SKILLS REQUIREMENTS
* Risk Management
* Investigation and Problem Solving
* Demonstrated technical capabilities
* Ability to establish appropriate timelines to meet key milestones under minimal supervision
* Deep knowledge of local, federal and international regulations
* Knowledge of human error awareness / prevention
* Organization skills
* Verbal and written communication skills (fluent in English)
* Works effectively in a team-based environment
* Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines
* Proficient in Microsoft Office applications
* Attention to detail
* Demonstrated ability to work with internal and external colleagues
* 6-sigma, lean or statistical skills
* Previous experience with methods in protein purification
* Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Equipment Change Control (CCDB) database, ERP (SAP) and Laboratory Information Management (LIMS) systems.
* Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
* Previous experience with batch record review, and process deviation investigations.
PHYSICAL POSITION REQUIREMENTS
Lift materials up to 40lbs
Ability to sit, stand and walk
Some travel may be required
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 email@example.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.