Quality Manager
PNEUMA RESPIRATORY
Boone, NC
Full-time
Manufacturing / Production / Operations
Posted on August 25, 2019
Quality Manager
Location: Boone, North Carolina
Job Purpose: This position contributes to the Company's success by managing the CGMP quality systems required to monitor the quality of third-party contract manufacturing organizations (CMO's) throughout the entire product lifecycle.
Top Reasons to Work for Us
- Competitive Salary
- The company pays 100% of health insurance
- Stock option grants
- Help build life-changing technology
Required Qualifications and Skills:
- Bachelor's degree in scientific/technical discipline
- 3+ years experience in the Biotechnology/Biopharmaceutical/Pharmaceutical industry with pharmaceutical or medical device products intended for human use
- 5+ years' experience working in progressively responsible positions in Quality Assurance, including final closure review of deviation/non-conformance investigations and batch disposition determination
- Experience interfacing with regulatory agencies (g., FDA)
- Strong analytical experience preferred
- Strong understanding of GMP, including 21 CFR 210 and 211, ICH guidelines and FDA requirements for pharmaceuticals
- Experience with CMO, CTL and packaging/labeling
- Strong organizational skills, conscientious in attending to detail
- Excellent written and verbal communication skills
- Demonstrated analysis and problem-solving skills
- Ability to work in a dynamic, fast-paced environment with shifting priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro