The vision of Sombra Cosmetic, Inc. is to continue the heritage of our Company and be a premier American manufacturer of top-quality products. We dedicate ourselves to be the supplier of choice when our type of products is being sought. This vision will be accomplished by sharing the responsibilities of planning and decision making with all our employees. Sombra will strive to maintain the image it has developed over the many years with its suppliers, customers, employees and community as a company of excellence.
Sombra Wellness Products is seeking a Document Control Coordinator to join our team!
The Document Control Coordinator will issue and maintain manufacturing batch (MBR) records. Issue and maintain discrepancy reports such as non-conformance, deviations, CAPA’s and other GMP related documents. Involvement with all FDA and OSHA documentation.
The Document Control Coordinator will report to the Compliance Manager.
The Document Control Coordinator will work in the quality control unit and will be responsible for Creating Master Manufacturing Batch Records and issuing MBRs to production. Will assist the Quality Control Associates in closing out production batch records and document control. Other duties and responsibilities included but not limited to are:
- Review and approve/reject of all in-coming components to include labels, containers and closures and raw materials.
- Maintain and issue master label copies.
- Maintain current all Standard Operating Procedures.
- Review batch records at the completion of production.
- Quality control oversight of batch manufacture.
- Monitor regulatory activity to maintain compliance with records and document management laws.
- Assist in determining document management policies to facilitate efficient, legal, and secure access to electronic content.
- Maintain all GMP related documentation.
- Other duties as assigned by the Compliance Manager.
Knowledge, Skills, and Abilities
- Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
- Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
- Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
- Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Writing - Communicating effectively in writing as appropriate for the needs of the audience.
Education and Experience
- High School or equivalent. Secondary education preferred.
- 0 - 2 years of experience in quality assurance or control.
- Experience working with ERP software system preferred.
- Knowledgeable in GMP’s, OTC drug manufacture and packaging highly preferred.
*Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
*Equal Opportunity Employer
