To manage the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site and ensure quality of the product/results, oversight of manufacturing and support operations and overall customer service.
Requirements
- Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field
- 5+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement
- Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs
- Excellent interpersonal skills and networking skills
- Ability to organize and prioritize multiple tasks
- Demonstrated strong problem solving and analytical thinking skills with strong attention to detail
- Demonstrated understanding of computer applications
- Demonstrated strong written and verbal communications skills
Responsibilities
- Manage the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site
- Oversee the department’s performance, resolution of quality issues, and regulatory compliance
- Conduct performance management and development of QA staff
- Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives
- Provide coaching/feedback to and develop QA employees
- Utilize Human Resources tools to ensure that the right individuals are in the right job
- Maintain and improve quality systems
Other
- Minimal travel (<10%) may be required
- Some off-shift work (night/weekend) may be required to support 24/7 operations
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
- Must carry a work mobile to support 24 hour/day operations
- Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field
