The Associate, Quality Control plays a vital role in supporting the integrity and consistency of raw materials through routine testing in a GMP-compliant laboratory environment. This position ensures analytical procedures are executed accurately and efficiently, maintaining strict adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The Associate collaborates closely with cross-functional teams to troubleshoot issues, optimize laboratory processes, and contribute to continuous improvement initiatives, all while handling hazardous materials safely. This role offers opportunities for growth within a dynamic quality assurance environment, fostering technical expertise and career advancement.
Key Responsibilities:
- Perform routine analytical testing of raw materials, including chemistry assays such as identification, loss on drying, pH, osmolality, and appearance.
- Execute laboratory activities in strict accordance with GMP and GDP standards, maintaining accurate and detailed documentation.
- Collaborate effectively with internal teams and stakeholders to support quality and manufacturing operations.
- Troubleshoot analytical issues, communicate findings clearly, and recommend corrective actions.
- Support departmental projects and continuous improvement initiatives to enhance laboratory efficiency and compliance.
- Properly handle, store, and dispose of hazardous materials, including toxic and flammable substances, according to safety protocols.
Qualifications:
- High school diploma or GED with 2 years of work experience, or Associates degree with 6 months of work experience, or Bachelors degree.
- Minimum of 4 years of experience performing analytical testing in a GMP environment.
- Experience with bench chemistry and compendial testing preferred.
- Strong understanding of GMP and GDP standards to ensure regulatory compliance and data integrity.
- Excellent troubleshooting, communication, and teamwork skills.
- Ability to maintain meticulous records and adhere to safety protocols.
Work Location:
Onsite - West Greenwich, Rhode Island