Job Details
Job Location: GenLabs - Winchester, KY
Position Type: Full Time
Salary Range: Undisclosed
Description
Position Summary
The Quality Assurance Technician (Quality Tech) will work closely with the Director of Quality Assurance and Control to ensure the consistency and quality of our products through internal and external monitoring and controls. The Tech will follow set processes and ensure adherence to good manufacturing practices (GMP), good laboratory practices (GLP), food safety prerequisite programs, and GenLabs safety and quality standards. Additionally, the Tech will demonstrate and potentially train others on cGMP compliance, serve as a resource, and adhere to the cGMP policy at all times.
Specific Responsibilities
- Inspect and sample incoming and outgoing products to ensure that all products conform to specifications
- Assist in verifying that finished products qualify for release
- Operate in compliance with all Company SOPs; report and discuss inspection results with those responsible for products and recommend corrective actions if necessary
- Maintain accurate documentation of quality inspection results
- Verification of COA’s
- Verify Packing Slips and/or Sales Orders
- Label creation and verification
- Prepare products for shipment
- Write and review new and current SOPs
- Assist in any capacity required by the Director of Quality or Chief Scientist
Qualifications
Education and Experience
- High school diploma. Bachelor’s degree - Preferred
- Minimum of one (1) year of work experience in a cGMP environment
- One (1) year of experience in Quality Assurance or Quality Control function – Preferred
- One (1) year of experience with product sampling, inspection procedures, customer complaints, product investigations, and CAPA - Preferred
- Ability to follow written and/or verbal directives and procedures
- Ability to create or update written procedures with site operations personnel
- Strong written and verbal communication skills; detail-oriented
- Utilizes critical thinking to troubleshoot issues
- Work collaboratively with a team to deduce root causes, advise solutions, and implement solutions
- Manage food safety prerequisite programs and cGMP audits using established KPI’s
- Other projects and tasks as assigned by the Director of Quality
Professional Qualifications
| Collaboration | With individuals of all levels, departments, and backgrounds, internal and external to the company. Everyone’s participation is important to your and our success |
| Commitment | Giving 100% effort 100% of the time |
| Communication | Effective listener, speaker, and writer |
| Integrity | Always doing the right thing, regardless of who is or is not watching |
| Personal Presentation | Always appear professional and in compliance with the dress code for the position |
| Respect | For yourself, co-workers, our customers, and vendor-partners |
| Time Management | Organize, prioritize, and execute multiple tasks in a fast-paced environment |
| Timeliness | Both in reporting to work and meetings and executing assigned task |