Based in Paramount, California, DLC Laboratories, Inc. is one of the nation’s leaders in health and beauty products for the Hispanic market. Founded in 1963, the company has grown rapidly in recent years, and our expanding product range is available in chain stores (e.g. Walmart, Target, CVS, Whole Foods, Walgreens and Rite Aid) and independents throughout the USA and in foreign countries.
DLC Laboratories, Inc. offers competitive compensation and excellent benefits.
As a member of the Quality Control Unit and Quality Assurance team, the QA Associate is responsible for coordinating regulatory related activities for the company including licenses, permits, inquiries, internal and external audits, and providing regulatory input on company processes and initiatives.
The successful candidate will be resourceful, detail oriented, and able to prioritize and meet deadlines in a fast-paced environment. This position reports to the QA/QC and Laboratory Manager.
DLC Laboratories, Inc. offers a competitive salary and excellent benefits. Salary will depend on education and experience. ($25 - $35/Hr.)
Responsibilities
1. Assist in the development, review and coordination of procedures to ensure ongoing compliance with governing standards from the FDA, California Department of Health and other regulatory bodies.
2. Participate as part of the company team that interacts with the FDA and other regulatory agencies.
3. Assist in the preparation and coordination of all ongoing and new regulatory submissions, both U.S. (e.g., Drug Listings, Establishment Registrations, Annual Reports, etc.), and international (e.g., Annual Foreign Site Applications, Technical Files, etc.). Provide regular status updates and activity reports.
4. Maintain professional and collaborative relationships with functional areas outside Quality Assurance.
5. Monitor and ensure appropriate ongoing Company-wide regulatory compliance with applicable cGMP standards and other pertinent regulations.
6. Coordinate and participate in external and internal audits, as required.
7. Organize and maintain regulatory records that include sanitation, complaints, mock recalls, pest control, safety inspections, crisis drills, vendor validation, SDS updates, etc.
8. Review, document, and follow up on reportable events, adverse reactions, and complaints.
9. Provide DLC employees with training on Quality Assurance matters.
10. Assist with company Environmental, Health and Safety projects.
11. Perform additional duties as assigned.
Skills and Qualifications
- Bachelor’s degree is required, preferably in the physical sciences.
- Minimum of 2 years of hands-on experience in Quality Assurance or Regulatory Affairs in the pharmaceutical, dietary supplement, food or medical device industry strongly preferred.
- Experience applying current Good Manufacturing Procedures (cGMP) guidelines preferred.
- Ability to work well independently and with others.
- Excellent organizational skills and attention to detail.
- Critical thinking skills and ability to follow through.
- Working knowledge of computer programs (Excel, Word, Outlook).
- Excellent written and oral communication, technical writing and editing skills.
Must be authorized to work in the United States on a full-time basis for any employer. Although we are grateful for all interest in our company, we will only contact those selected for an interview. No phone calls, please.
Job Type: Full-time
Benefits:
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
Schedule:
- 8-hour shift
- Monday to Friday
Ability to commute/relocate:
- Paramount, CA 90723: Reliably commute or planning to relocate before starting work (Required)
Education:
Experience:
- FDA regulations: 1 year (Preferred)
Shift availability:
Work Location: Paramount, CA 90723
Job Type: Full-time
Pay: $52,000.00 - $72,800.00 per year
Benefits:
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- FDA regulations: 1 year (Preferred)
Shift availability:
Work Location: Hybrid remote in Paramount, CA 90723