Quality Assurance Specialist

Summary of Job Duties: 

Provide documentation support to Manufacturing and Packaging to ensure compliance with 21 CFR Part 111 in the development and review of Master Manufacturing Records and Production Batch Records and any associated deviations or change controls generated in production.

Specific Job Duties:

1. Review documentation (SOPs, master manufacturing records, production batch records, etc.) to ensure compliance with cGMPs.

2. Work with Production and Quality Control to correct any noted deficiencies/inconsistencies which may impact compliance.

3. Insure all calibration schedules are met, broken equipment is removed from service and reported to appropriate repair companies.

4. Prepare appropriate metrics for Management Review.

5. Participate in Internal Audit, Validations and ongoing GMP trainings.

6. Any other duties and functions as assigned by Management.

Minimum Qualifications Required:

1. Associates or 4-year college degree
2. 2 years in QA experience in an ISO or GMP environment
3. Excellent written and verbal communication skills
4. Experience with Microsoft Office
5. Strong attention to detail and organizational skills

Skills and/or Training Desired:

1. Familiarity with GMPs - specifically 21 CFR 111 for Dietary Supplements.
2. Quality Assurance or Quality Control working experience.
3. Previous experience with internal auditing.

To Apply For This Position

Send your resume to:

Threshold Enterprises, Ltd.
Attention Human Resources
23 Janis Way
Scotts Valley CA 95066

resumes@thresholdent.com

fax (831) 461-1288

Applications are available in building 19 Janis Way in Scotts Valley.

Threshold Enterprises is an Equal Opportunity Employer.

Established in 1978, Threshold Enterprises is a well known national nutritional supplements distributor and manufacturer of award winning Source Naturals® and Planetary Herbals™ brands. The company's brands are sold through more than 7,000 store Health Food Store and internet channels. The company has grown significantly through exceptional channel relationships, product innovation and the reputation of its brands for potency, quality and value. Threshold Enterprises is one of Santa Cruz County's larger employers, with over 850 employees.