Job Details
Job Title: Quality Control (QC) Technician - Over-the-Counter (OTC) Manufacturing
Overview: We are seeking a meticulous and experienced Quality Control (QC) Technician specialized in Over-the-Counter (OTC) manufacturing to join our team. The ideal candidate will have a strong background in quality assurance procedures and a keen eye for detail. As a QC Technician, you will be responsible for ensuring that all products meet the required standards of quality, safety, and efficacy. This role plays a critical part in our commitment to delivering high-quality OTC products to our customers.
Responsibilities:
1. Conduct routine inspections and quality tests on raw materials, in-process samples, and finished OTC products to ensure compliance with established specifications and regulations.
2. Maintain and calibrate laboratory equipment to ensure accurate and reliable results.
3. Document all test results, observations, and deviations accurately and promptly in accordance with Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
4. Investigate and troubleshoot any deviations or out-of-specification results, collaborating with other departments as necessary to identify root causes and implement corrective actions.
5. Participate in internal audits and regulatory inspections, providing support and documentation as needed.
6. Assist in the development and validation of analytical methods and procedures.
7. Stay updated on industry trends, regulatory requirements, and best practices related to OTC manufacturing and quality control.
8. Collaborate with cross-functional teams including Production, R&D, and Regulatory Affairs to ensure product quality and regulatory compliance throughout the manufacturing process.
9. Contribute to continuous improvement initiatives aimed at enhancing efficiency, quality, and safety within the QC department and across the organization.
Requirements:
1. Bachelor's degree in Microbiology, Chemistry or Biology. Preferred.
2. Minimum of 2 years of experience working in a quality control role within the OTC manufacturing industry.
3. An understanding of cGMP regulations and FDA guidelines pertaining to OTC products.
4. Experience with laboratory instrumentation and equipment.
5. Excellent attention to detail and accuracy in documentation.
6. Effective communication skills, both verbal and written, with the ability to collaborate across departments.
7. Proven problem-solving abilities and the capacity to work independently as well as part of a team.
8. Familiarity with quality management systems (QMS)
9. Ability to adapt to changing priorities and work in a fast-paced environment while maintaining a high level of professionalism and quality.
10. Experience with process validation, Equipment qualification and cleaning validation.
Preferred Qualifications:
1. Preferred Bachelor s degree in a relevant scientific discipline.
2. Previous experience with method development and validation.
3. Knowledge of statistical analysis software for data interpretation.
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Location: Tampa Florida
Salary Range: $20 - $25/hr
Position reports to: Quality Manager
Start date: Immediate.