Production SOP Writer

Summary of Job Duties: 

Perform a wide variety of duties to ensure compliance with applicable Regulatory Requirements in the areas of Document Control and GMP Training.  Develop and review various types of documentation including SOPs, Work Instructions, Forms, Flow Charts, and any other documentation required to support the Quality Management System (QMS).  Maintain original “Controlled” filling systems for Document Control and GMP Training.  Perform all administrative functions to support the Document Control and GMP Training Quality Systems.

Specific Job Duties:

1. Manage and monitor all phases of the cGMP Trainings and other departmental training records.
2. Create forms, logs, flow charts and data collection as needed for our department compliance.
3. Responsible for all controlled documentation, cGMP’s records and retention program in Production.
4. Edit and update, Standard Operating Procedures documentation for the Production department.
5. Responsible for creating guidelines for Production department.
6. Maintain the confidential document control files and GMP training files.       
7. Assist in GMP Training activities, as needed.
8. Assist the QA Manager in the development of Document Control processes and practices.
9. Assist Production Supervisors in any given tasks regarding compliance of GMPs and SOPs company wide.

Minimum Qualifications Required:

1. 2 to 3 years relevant experience working with confidential controlled documents.
2. Excellent written and verbal communication skills
3. Experience with Microsoft Office applications (Excel, Word, Outlook, etc.)

Skills and/or Training Desired:

1. 2 to 3 years working with document change control in a manufacturing environment.
2. Familiarity with GMPS-specifically 21 CFR Part 111 for Dietary Supplements.
3. Strong attention to detail and organization skills.
4. Strong administrative skills and experience.

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.