The Quality Assurance Specialist is a person with knowledge of FDA regulations and ISO 13485 Regulations that will assist in administering the quality stability program.
The lab Supervisor performs basic to complex analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Laboratory procedures and is responsible for the overall functioning of the lab. Completes test methods or other required documentation and performs laboratory cleaning and basic maintenance. Administers the quality stability program and other quality duties.
Perform testing on existing products and other duties as described below.
1. Ensure that quality documentation and records follow internal requirements.
2. Responsible for executing different laboratory tests, making observations, performing data analysis and reporting results.
3. Knowledgeable on proper lab procedures and lab book documentation.
4. Adherence to regulatory requirements and production schedules.
5. Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, investigation reports, regulatory submissions, etc.
6. Help maintain the department laboratories, records, equipment, and procedures in line with current Quality Management System compliant with cGMP, GMP, and ISO 13485.
7. Identify deviations and report possible preventive and corrective actions.
8. Working knowledge of proper lab and production cGMP, GMP and ISO 17205 requirements.
9. Identify lab materials needed for existing to carry out analytical testing.
10. Lead in all failure investigations (OOS) of lab tests that are out of specification.
11. Recognizes obstacles to technical or process related issues and can independently resolve them.
12. Other lab duties may be assigned by the quality manager as needed.
13. Administer and monitor stability test for new and existing products as required.
14. Manages lab workflow and ensuring timely completion of test and procedures.
15. Manages inventory of laboratory equipment, reagents and supplies.
16. Coordinates maintenance and calibration activities with the Quality Manager.
1. Technical abilities should include knowledge of the drug development process.
2. Thorough understanding of risk management as relates to laboratory activities.
3. Team player; takes to heart the importance of individual contribution within the team. Mind set of supporting all team members within Elevate to achieve their full potential.
4. Self-starter: be bold, take the initiative to start agreed upon strategic and tactical operations and initiatives to advance Elevate and its Team Members.
5. Ability to communicate effectively (verbal and written) with a wide variety of audiences (operators, management, etc.).
6. Ability to guide the stability program.
1. Bachelor’s Degree with at least 2 years of laboratory experience; Associate degree with at least 4 years of laboratory experience.
2. Processing experience in a wide variety of dosage/delivery forms.
3. Demonstrated proficiency in the use of laboratory instrumentation and Microsoft Office suite of software.
Job Type: Full-time
Pay: $85,000.00 - $92,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Schedule:
- Monday to Friday
Ability to Commute:
- West Palm Beach, FL 33411 (Required)
Ability to Relocate:
- West Palm Beach, FL 33411: Relocate before starting work (Required)
Work Location: In person