Quality Assurance Manager/Team Leader - mAbs/B2 Operations

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.
We manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow.
Benefits Include:
Great Health Benefits from day 1!
4 weeks accrued paid vacation and 13 paid holidays
401(k) match with company profit sharing
Tuition reimbursement
Student Loan Repayment Program
 
Position Summary
The QA Manager/TL is accountable for ensuring cGMP compliance within the site's B2 MAb and 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: 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 ABI/MAb manufacturing within Zoetis Lincoln Biological Operations. Assist with transfer of new monoclonal antibody (Mab) biological therapeutic products and ABI products into GMS. This position will lead a team of 5 compliance specialists and support all associated activities. 
 
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 and efficiently. Communicate effectively and decisively with manufacturing team members as well as members of site management. Work with a team to meet 
 
The QA Manager/TL will also interface directly with regulatory agency, customers, and internal auditors, provide support for market action activities, and will assist in the identification and communication site and department metrics.
Position Responsibilities
·         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 10 years of relevant experience. M.S. degree is preferred.
 
Technical Skills and Competencies Required
Minimum Qualifications:
·         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
Preferred Qualifications:
·         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

 

 

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.

 

 

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.

 

 

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.

 

 

World's largest animal health company, developing medicines, vaccines, and diagnostics for livestock and pets. Based in Parsippany, NJ.

zoetis.com