The QA Incoming Inspection Technologist is responsible for performing and maintaining material evaluation and release expectations and tasks necessary to ensure all regulatory and departmental documents are in compliance with regulations and company policies. The QA Incoming Inspection Technologist is also responsible for the identification and escalation of areas of risk associated with vendors and materials, support the qualification of new vendors / materials and site project initiatives.
The QA Incoming Inspection Technologist will also occasionally interface directly with regulatory auditors, customer and internal auditors, provide support for market action activities and will assist in the identification, collection and communication of site and department metrics and other duties as assigned.
- Ensures cGMP compliance within the biological and pharmaceutical Material System
- Status management of materials
- Sampling of materials
- Evaluation and archival of samples
- Documentation review
- Contributes with the qualification of new materials and vendors
- Accurately records each inspection or test result into the appropriate records.
- Assist with vendor related investigations and vendor management activities
- Interpretation and enforcement of 21CFR, EU and other regulatory guidelines
- Provides guidance and support within biological and pharmaceutical Material System
- Support regulatory agency, customer and internal audits
- Review and approval of action items / commitment tracking items / interim reports
- Support Warehouse and Material Management activities
- Perform internal audits / process checks
- 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 2 years of relevant experience, Preferred
- High School diploma or 2-year degree with at least 4 years relevant experience
Technical Skills and Competencies
- Strong written and oral communication and ability to work effectively on a team.
- Ability to establish appropriate timelines to meet project milestones under minimal supervision.
- Process and detail oriented with the ability to follow processes and prepare detailed structured documents.
- Ability to develop solutions to routine problems following procedures.
- Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.
- Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
- Risk Management
- Problem Solving
- Demonstrated ability to identify issues
- Awareness of local, federal and international regulations
- 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
- Demonstrated knowledge of the Deviation (ETS), Change Control (ETS)
- Self-directed – can work with little or no supervision on most tasks
- Experience in change management processes, manufacturing operations, quality operations, regulatory affairs, warehouse operations, product release, change management and/or vendor management
Physical Position Requirements
- This position requires sitting, standing, and walking with occasional overtime/weekend work.
- Lift materials up to 40lbs
- Must wear appropriate PPE (Personal Protective Equipment) in manufacturing/production areas