Regulatory Compliance Specialist Avient Biosciences, LLC Wilson, NC 27893

Join the East Coast’s premier industrial hemp derived cannabinoid ingredients manufacturer. North Carolina is quickly becoming the center of Industrial Hemp cultivation and processing and Avient Biosciences is leading the way. Our mission is to make cannabis health available to everyone by providing safe, consistent and effective cGMP cannabinoid ingredients of the highest quality to retail product manufacturers everywhere.

As our Regulatory Compliance Specialist you will be responsible for activities of the Regulatory Affairs and Quality Departments.

Your main objective is to ensure our regulatory and quality compliance – specifically with FDA, OSHA, EU, and all federal, state, and local regulatory authorities. If you’re tired of bureaucratic decision-making, join our small, privately-owned, strong team. You’ll be making a significant impact in our company as a senior level contributor.

Duties and Responsibilities:

  • Lead the FDA inspectors and other auditors during inspections and address all other issues.
  • Develop Drug Master Files, ISO 9001, EU-GMP or other process documents for registrations and periodic submissions.
  • Review and submit Annual Reports, Periodic Reports, Annual Drug Reviews, Adverse Drug Experiences and Recall Coordination Activities, and supplements to FDA.
  • Participate in quality and regulatory meetings, evaluate project priorities and coordinate activities to facilitate the reaching of objectives in a timely manner.
  • Develop and maintain regulatory knowledge by keeping abreast of regulatory, pharmacopeia and cGMP changes.
  • Act as subject matter expert for drug and food products, when customer inquiries occur.
  • Write, review and revise SOP’s, in compliance with the regulations.
  • Assist with quality systems with respect to Investigations, Change Controls and Corrective and Preventive Actions.
  • Provide regulatory/technical input for product development / launch and reformulation.
  • Respond to OOS’s, deviations, complaints and other deficiencies.
  • Perform other activities as necessary.

Qualifications:

  • Masters in Biochemistry, Biology, Pharmaceutical Sciences or related field is a minimum. A Pharm D, PhD, or advanced degree in a scientific/technical discipline is strongly recommended.
  • Five years of pharmaceutical industry experience and a minimum of five years leading audits with FDA. Candidate must show strong negotiation skills and significant experience in proactively and reactively interacting with regulatory authorities.
  • Must be able to demonstrate leadership.
  • Must have ability to work on long-term projects independently. · Must have excellent communication skills – verbal, written, and interpersonal.
  • Must have strong analytical, strategic, organizational, reporting and presentation skills.

Full-time Position

Salary based on experience and knowledge of industry processing

Benefits:

  • Health insurance, including vision and dental
  • Paid time off
  • Life insurance

Schedule:

  • Monday thru Friday 8:30 AM -5:30 PM.

Job Type: Full-time

Benefits:

  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Ability to Commute/Relocate:

  • Wilson, NC 27893 (Required)

Education:

  • Master’s (Preferred)

Experience:

  • pharmaceutical industry: 5 years (Preferred)

Work Location:

  • One location

Work Remotely:

  • No

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