We're a family owned and operated company, which has been manufacturing pharmaceuticals since 1966. Join our 25-person team in a vital role. Help us market quality products designed to help chronic wounds heal. Visit www.getdakins.comfor more company and product information. Please contact us if this sounds like it might be a good fit with your goals. This is a full-time position, and you must have a BS degree in a related field.

Job Description:

Formulate and refine the company’s current Quality System. Plan and direct the Quality Assurance / Control program, designed to insure continuous production of products consistent with established standards. Plan, promote and organize training programs related to the company’s Quality System.

Education and Experience:

BS Degree in chemistry or biology, with 3 – 5 years experience in Quality Assurance in the pharmaceutical or medical device industry. Must have a working knowledge of GMP requirements.

Job Duties:

• Responsible for directing QA Techs and Chemist in daily priorities and responsibilities.
• Audit Manufacturing, Packaging and Lab paperwork for accuracy and completeness.
• Monitor the QA Technician’s work, specifically making sure stability tests are completed on time.
• Analyze the stability test results and take follow up action based on those results. (For example, schedule any tests needed in addition to those normally scheduled.)
• Train employees with regard to following the company’s SOP’s and its Quality System. Follow up to ensure employees understand and comply with SOP’s.
• Investigate and respond to OOS’s, deviations, complaints and other deficiencies.
• Audit various departments, as assigned by the Director of Regulatory Affairs, on a yearly basis. Write up the audits and present them to the Management team, including suggested improvements and timelines for completion.
• Review product labels and recommend appropriate changes as needed, or as determined by new evidence or regulations.
• Work with the Operations Manager to communicate changes in manufacturing, packaging, labeling, or other processes or procedures.
• Perform a 2nd person in-process review of lab procedures performed by the Chemist.
• Have a working knowledge of all cGMP rules and regulations, and develop a system of effectively implementing them, according to written guidelines.
• Have a working knowledge of ICH guidelines and of laboratory regulatory guidelines.
• Participate in Quality Meetings, presenting ideas to management for improvement.

Preferred experience but not required:

• Basic knowledge of wet chemistry, microbiological experience, and product stability testing.
• Knowledge of ISO regulations.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
Twice daily sanitation of offices. Plexiglass desk dividers. CDC recommendations/requirements are followed.

Work Location: In person