Compliance and Document Control Coordinator

Description

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.

Summary: Work with manufacturing operations and QA/QC to support GMP and ISO compliance. Assist in developing processes and documentation for compliance purposes. Collaborate with multiple departments in the drafting and publishing of documentation and revise as necessary. Participate in training operations personnel to ensure GMP and ISO compliance. Participate in managing documents in the document control system (QT9). Assist in regulatory audits and provide internal audit support. This position is a hybrid position, reporting onsite to our Prineville, Oregon facility 3 days a week. 

Responsibilities: 

• Assisting in QT9 document control system for GMP document.

• Co-managing corrective actions, training, SOPs, calibrations, internal and external audits, risk management, equipment files, customer support, supplier management, etc. in QT9

• Managing corrective action effectiveness evaluation in QT9

• Organizing and maintaining all GMP documents in QT9 (i. e. logbooks, forms, etc.)

• Composing and reviewing technical documentations such as technical reports, development reports, risk assessments, process validation protocol/reports.

• Supporting all activities related to document control in GMP Manufacturing.

• Controlled document preparation, routing, supporting document creation/change system.

• Publishing controlled copies of approved documents (SOPs, forms, procedures, specifications, production batch records, training material, training quiz, etc.)

• Trending all scientific and technical data on production batch records, environmental monitoring, stability studies, etc.

• Supporting management during regulatory agency, ISO, NSF, and customer audits.

• Other manufacturing document control related tasks as applicable.

• Performing and maintaining glass and brittle plastics program.

• Overseeing and storage of pest control program reports.

• Assist in supplier qualifications both outgoing and incoming.

Qualifications

Qualifications:

• Associate degree as a minimum: bachelor degree in chemistry or biochemistry preferred.

• One year experience in a regulated industry as a minimum.

• One year experience in QT9 management as a minimum.

• GMP documentation experience preferred.

• Experience in scientific technical writing preferred, but not required.

Work Remotely

• Hybrid

Job Type:

• Full-time

Education:

• Associate degree / Bachelor

Experience:

• QT9 Management or other relevant QMS experience : 1 year

• Knowledge of 21 CFR Part 111, ISO Standards, FSMA, PCQI preferred