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Quality Manager

Employer
PNEUMA RESPIRATORY
Location
Boone, NC
Start date
Aug 25, 2019
Closing date
Sep 23, 2019

View more

Category
Biotechnology, Healthcare, Management
Job Type
Employee
Employment Status
Full Time

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 (CMOs) throughout the entire product lifecycle.

 

Top Reasons to Work for Us

1.  Competitive Salary

2.  Company pays 100% of health insurance

3.  Stock option grants

4.  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

 

Summary of Key Responsibilities:

  • Manage all aspects of quality systems, such as change control, deviations, investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events
  • Manage Company's Quality Compliance in maintenance of site training, supplier management, internal audits and related functions
  • Contribute to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and Company quality standards in support of cGxP activities
  • Manage the QA batch release function for cGMP commercial manufacturing and distribution activities from the CMO facilities
  • Contribute to preparation and/or review of annual product review and updates for regulatory filings, batch release metrics and department reporting, as applicable
  • Participate in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects
  • Prepare and/or review controlled documents (g., SOPs) required for compliance

Other duties as assigned by manager

Job Type: Full-time

Experience:

  • Biotechnology / Medical Device / Pharmaceutical industry: 7 years (Preferred)
  • Quality Assurance: 5 years (Required)

Work authorization:

  • United States (Required)

 

Reply to: jobs@pneumarespiratory.com

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