About GVB Biopharma
GVB Biopharma, a 22nd Century company, is a global-scale specialty ingredient supplier and contract development & manufacturing organization (CDMO) with manufacturing locations in Nevada and Oregon. GVB is the largest merchant provider of cannabinoid extracts and isolates in North America with a focus on cannabidiol (CBD) and cannabigerol (CBG) extracted and refined at an industrial scale into distillates and isolates. GVB Biopharma’s facilities are NSF International audited and are cGMP Registered for dietary supplements manufacturing. GVB is widely regarded as a best-in-class operator with a leading position in the hemp-derived active ingredients market, with around 15% market share and growing. GVB is also a white-label contract manufacturer of tinctures, gel capsules, gummies, mints, tablets, topical, and vape offerings.

The Quality Assurance Manager will be responsible for continued development and oversight of our Las Vegas facility's quality management system for cGMP-certified manufacturing of dietary supplement ingredients. We are seeking an experienced quality person to support the company’s future certification for the production of finished goods products. This is a full-time position with a Monday through Friday schedule from approximately 8:00am – 4:00pm. Flexibility in the Quality Manager’s schedule to meet production support needs will be required.

Responsibilities:

• Implement procedures to comply with federal regulations for the manufacture of products according to 21 CFR Part 111

• Guidance and manage the company’s certification process for cGMP and NSF

• Write, review, approve, and retain standard operating procedures (SOPs), work instructions, validation protocols and reports, logs, and other related GMP documentation

• Review, approve, and retain quality system related records (e.g., deviations, change control, CAPAs, incidents and OOS investigations) for completeness and accuracy

• Ensure staff are trained on activities being performed and mentor team members with respect to quality

• Inspect all incoming materials prior to use in manufacturing and all outgoing finished product prior to shipping to clients to make a decision to accept or reject batches

• Plan, schedule, and conduct regular internal audits, in-process inspections, and finished product inspections.

• Plan, schedule, and be the main point of contact for external audits, including for FDA cGMP and third-party standards

• Manage customer complaints and plan, schedule, and conduct customer audits regularly

• Complete customer supplied forms in a timely manner

• Bachelor’s degree in relevant field

• Strong Working knowledge and understanding of cGMP under 21 CFR Part 111

• 10+ years of relevant experience in a cGMP environment producing products in accordance with federal requirements for dietary supplements, and or food ingredients

• 5+ years of relevant supervisory and project management experience

• Proven ability to revise and update SOPs and policies to comply with regulatory requirements

• Experience with Statistical Process Controls (SPC)

• Ability to effectively organize, prioritize, and work in a fast-paced, deadline driven work environment.

• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.

• Small operational / start-up experience preferred

• Creativity to solve technical and compliance problems

• Excellent written and oral communication skills

• Computer knowledge, including Microsoft Word, Excel, and PowerPoint

• Bi-lingual English/Spanish Oral and written

Preferred Qualifications

• PCQI and HACCP Certifications (or similar)