SUMMARY: Westwood Laboratories Inc. is a leading contract manufacturer specializing in consumer and professional products within health and beauty, over-the-counter (OTC), pharmaceuticals, therapeutic drugs, medical devices, pet care, and personal care topical products. Established in 1948, Westwood Laboratories is an FDA-licensed pioneer in product development and quality custom manufacturing. Our dedicated professional team is committed to advancing cosmetic and drug formulations while providing unparalleled customer service.
JOB DUTIES AND RESPONSIBILITIES
The Document Control Specialist performs complex work of an administrative nature. Providing assistance to various department managers, working with minimal instruction or supervision.
Responsibilities will include, but are not limited to, the following:
- Responsible for establishing and maintaining accurate, current files on all related documents, literature, and materials.
- Manage the change control program by issuing change control numbers, collecting and routing change documents to stakeholders, and maintaining a change control log.
- Manage training matrix, scanning and filing training records.
- Prepare documents (certificate of analysis, master dossier, specifications, procedures, methods, forms, etc.) in an approved format for signatories. Documents may include highly confidential information which should be treated accordingly.
- Responsible for issuing accurate, error-free written documents.
- Audit and prepare monthly reports on the Cost of Quality (OOS, NCRs, CAPA, Return Goods, Customer Complaints, Yield Discrepancies, Labeling Discrepancies, and Hold Items)
- Track outside testing reports and billing.
- May do research for a project or a specific matter
- May receive visits or calls regarding complaints, customer comments, and instructions, which may be resolved or referred to the appropriate person.
- Organize and expedite the workflow through the department head’s office. Keep the department head(s) updated with the day’s events and occurrences.
- Manage projects and daily required testing to outside labs, as well as ongoing follow-up to ensure timely response for results
- Perform other duties as assigned by the Supervisor and/or Head of Quality and Regulatory Affairs
- Retrieves information from the computer system as requested
- Respond quickly to requests for technical information and to problems as needed
- Track and manage SOP’s review/revision as required
QUALIFICATIONS
- An associate degree or higher in business administration or related field
- 3-5 years of experience in Document Control
- Strong communication and interpersonal skills and interact well with widely diverse groups
- Attention to detail
- Experience working with many types of files
- Effective communication skills across all departments
- Expertise in the manufacture and control of finished OTC/cosmetic/personal care products
- Excellent written and verbal communication skills