Supervisor, Quality Systems
Akorn 2

Somerset, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


Participate and lead cross functional and departmental teams responsible for ensuring completion of all FDA, other regulatory authority and internal audit commitments as well as commitments arising from any Akorn Quality Improvement initiatives for the Somerset site. Work with site functional SMEs to ensure all commitments are closed within the required timelines and have adequate supporting documentation to support closure.

  • Participate and lead cross-functional and departmental teams to ensure timely completion of FDA, other regulatory authority and internal audit commitments as well as commitment arising from any Akorn Quality Improvement initiatives.
  • Perform and or facilitate completion of gap analyses and implementation plans for corporate quality procedures.
  • Interact with counterparts at other Akorn sites and corporate functions to harmonize Quality System implementation across sites.
  • Participate in the Aseptic Train-the-Trainer program as an Akorn Site Certified Aseptic Trainer.
  • Provide site representation and subject matter expertise on Akorn Quality Improvement initiatives involving aseptic processing operations.
  • Track and communicate status of projects to site and corporate management and project stakeholders.
  • Support site audits as required.


Qualifications
  • Bachelor’s Degree (BS or BA) in a science related field (i.e. math, chemistry, biology) or equivalent experience required.
  • Five years pharmaceutical industry experience required.
  • Excellent interpersonal, oral, and written communication skills.
  • Requires exceptional attention to detail with the ability to focus on current assignments.
  • Must have accomplished skills in computer-assisted documentation systems.
  • Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
  • Must have a teamwork attitude.
  • Will interact with all functional departments within the company including hourly, professional and management personnel.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times, it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.




Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


This job has expired.

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