Quality Assurance Raw Material Specialist

Zoetis is the worlds largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln NE we manufacture high quality medicines for dogs cats and livestock. Our plant has been recognized as one of the Nebraskas Safest Companies with a long-standing presence in the Lincoln community. We are a clean modern site that continues to innovate and grow.

Benefits Include:

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health personal and family benefits starting day 1.

Position Summary

The Quality Assurance Raw Material Specialist is responsible for overseeing the quality control and release of raw materials used in pharmaceutical and biological production. This role ensures that all incoming raw materials comply with regulatory requirements company standards and product specifications. The specialist will collaborate with various departments including procurement manufacturing regulatory affairs and quality control to maintain the highest standards of material quality.

Hours: 1st shift.

Position Responsibilities

• Raw Material Inspection & Testing:

• Perform maintenance activities on specifications sampling requirements and documentation of incoming raw materials to ensure they meet established procedures and quality standards.
• Coordinate with warehouse personnel for the sampling of raw material and laboratory personnel for testing raw materials according to predefined specifications and standard operating procedures (SOPs).
• Review and approve laboratory test results and reports for material acceptance or rejection.

• Supplier Management:

• Collaborate with the procurement team to qualify new suppliers and supplier changes.
• Conduct evaluations of supplier documentation to ensure consistent raw material quality and compliance within regulatory guidelines.
• Address quality-related issues with suppliers through investigation of material nonconformances.

• Material Release:

• Ensure the timely release of raw materials for production by verifying that all quality requirements have been met including documentation review and approval.
• Maintain proper documentation and records of raw material inspections test results and release status in compliance with Good Manufacturing Practices (GMP).

• Documentation and Compliance:

• Maintain accurate records for raw materials including certificates of analysis (COAs) specifications and any deviations or non-conformances.
• Ensure compliance with relevant regulatory agencies (e.g. FDA EMA USDA) and internal quality systems including GMP Zoetis Quality Standards and Zoetis Global Procedures.
• Support internal and external audits by providing necessary documentation and evidence of quality processes.

• Continuous Improvement:

• Identify opportunities for process improvements in raw material handling testing and release procedures.
• Participate in cross-functional meetings to address quality concerns and propose solutions for improving the overall quality system.
• Provide training to team members on best practices related to raw material quality control and regulatory requirements.

• Risk Management & Investigations:

• Investigate raw material quality deviations or non-conformances determining root causes to support suppliers investigations and agree to corrective and preventive actions (CAPAs).
• Assist in risk assessments related to raw material quality and ensure appropriate controls are in place to mitigate identified risks.

Education and Experience

• Bachelors degree in Chemistry Pharmacy or related field.
• Minimum of 3-5 years of experience in pharmaceutical/biological manufacturing or quality assurance/control.
  • Job level based on years of relevant experience and working regulatory knowledge:
    • For the GJL 040-2 level
      • Minimum 3 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations in a pharmaceutical or biotech setting.
    • For the GJL 060-1 level
      • Greater than 4 years experience at an Associate Staff level position specifically in raw material management in a pharmaceutical or biotech setting.
    • For the GJL 060-2 level
      • Greater than 5 years experience at a Staff level position (060-1) specifically in raw material management in a pharmaceutical or biotech setting.

Technical Skills and Competencies Required

Technical Skills

• In-depth knowledge of Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) and relevant regulatory requirements (FDA EMA USDA etc.).
• Experience with raw material testing including wet chemistry and analytical methods such as HPLC GC and FTIR is a plus.
• Strong understanding of risk management principles and CAPA processes.
• Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
• Experience working within a GMP regulated Biotech or Pharmaceutical industry.
• Proficiency in quality management systems (QMS) e.g. ETS Veeva Vault LIMS and enterprise resource planning (ERP) software i.e. SAP.
• Experience with MS Word Excel Outlook and Teams

Key Competencies

• Detail-oriented with strong organizational skills.
• Problem-solving and critical thinking ability.
• Ability to work under pressure and manage multiple priorities.
• Commitment to quality and continuous improvement.
• Ability to make independent decisions based off industry and regulations knowledge.
• Demonstrated ability to write and review technical documents with high attention to detail.
• High integrity and self-motivation

Physical Position Requirements

The position is primarily office based with a significant amount of time spent sitting/working at a computer and processing paperwork. Handling of Raw Material (chemical) Samples required. Periodic weekend work and off-shift work 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 @ 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 @ 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 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 site or (2) via email to/from addresses using only the Zoetis domain of @. 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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.