Quality Assurance Specialist (Night)

Open Book Extracts

Quality Assurance Specialist - Night Shift

The Company

Open Book Extracts is the complete source for hemp-derived cannabinoids, including wholesale raw ingredients, emulsions, custom formulations and EasySnaps.

The Position

We are seeking an experienced Quality Assurance Specialist - Night Shift who will be responsible for regular sampling of in-process and finished goods, data entry, and organization of samples. The Quality Assurance Specialist - Night Shift must bring a high level of energy and possess the attitude and flexibility to adapt to the evolving regulatory landscape of the industry. This position will report to the Quality Manager and perform both Quality Assurance and Quality Control functions

Responsibilities

• Inspections and Product Analysis
  • Conduct product inspections in accordance with recommended guidelines as listed in Company SOPs for the release of products for shipment.
  • Document test results and any required reports in real time and maintain records electronically and physically.
  • Conduct regular review and disposition of Certificate of Analysis for company use.
  • Complete swab-based environmental monitoring as directed.
  • Conduct Petrifilm plating for samples as directed.
  • Ensure standardized tests on products meet standards and regulations regarding factors including but not limited to: labeling compliance, product quality, consistency and other factors such as chemical composition, sensory evaluation, and contaminant evaluation (microbiology, residual solvents, heavy metals, pesticides.).
  • Report out of specification events in a prompt and timely manner in accordance with Company policies.
• QC Laboratory responsibilities
  • Complete sample preparation on production samples to ensure they are ready for day shift to analyze on the HPLC and UPLC instruments.
  • Ensure instrumentation is properly calibrated
  • Strict adherence to cGMP guidelines
  • Proficiency in wet lab skills (pipetting,dilution, weighing,data entry)
  • Willingness to learn basic chromatography techniques
  • Able to accurately interpret chromatograms and convert the information into data that the production team can use for their process
• Documentation audits
  • Conduct routine documentation audits to ensure manufacturing records are completed, following ALCOA requirements.
• Complete all required training and adheres to company's SOP (standard operating procedures)

Experience

• HS or equivalent required
• Solid understanding of Quality Assurance cGMP requirements for global regulatory filing Experience in FDA (food, dietary supplements, and pharmaceutical) environments preferred.
• Experience in the food, dietary supplement , or pharmaceutical industry over 1 year is preferred.
• High level of interpersonal skills, strong leadership abilities, organizational and time management skills.
• Excellent communicator.
• Ability to work independently and meet deadlines.

Other Details

• This is a full-time position based out of Roxboro, NC
• Work schedule is Tuesday - Saturday, 7pm-3am; hours subject to change.
• Compensation commensurate with experience.
• Background and reference checks required.

Physical Demands and Working Environment:

• Must be able to lift, carry and balance up to 50 pounds
• While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and repetitive motions.
• Ability to walk and stand for long periods of time (5-6 hours) with frequent kneeling and bending.
• Working in limited climate-controlled facilities and may experience extreme heat or cold
• Work with heavy fumes, plants, airborne particles and chemicals
• Must be comfortable working with and around heavy machinery
• May experience moderately high noise levels

Equal Employment Opportunity Statement

Open Book Extracts is proud to be an equal opportunity employer. We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.