QC Analyst III-Chemistry

Role Summary

The QC Analyst III is responsible for the performance and reporting of analytical testing in support of product production and release, as well as developmental assays, as required. The QC Analyst III helps provide delivery of compliant laboratory systems and data in support of Organogenesis products, and in accordance with appropriate regulatory, corporate and scientific guidelines. In addition, the QC Analyst III will also provide input in support of method validation, cleaning validation, process validation, and characterization activities. In this position, the QC Analyst III will also interact with external entities including contractors and suppliers.

Responsibilities

• Perform chemical analysis and ELISA assays for raw materials, intermediates, and finished product testing.
• Demonstrate knowledge in analytical test methods to support in-process, raw materials, and routine final product test samples.
• Prepare and send out samples for testing, when necessary.
• Perform visual inspection of finished product.
• Generate trend reports, as they relate to Quality testing.
• Author and revise SOPs.
• Identify and implement issues and opportunities for improvements.
• Participate extensively in high-level quality systems programs (CAPA, etc.).
• Interact with Manufacturing and other departments to ensure support of processes and product testing.

Qualifications

• BS in a relevant scientific discipline (i.e., Chemistry, Biology, Biochemistry).
• 5+ years of experience in a cGMP Quality Control Department in a FDA-regulated industry.
• In-depth knowledge of compendial (USP, EP) test methods, and relevant ICH and FDA guidelines.
• Technical and Scientific Proficiency.
• Proven technical proficiency and demonstrated skills in quality technology practices.
• Demonstrates understanding of relatively complex data with proficiency to problem solve.
• Data Analysis Requirements.
• Proficient in the use and application of quality tools, databases, and process skills.
• Regulatory Requirements.
• Advanced knowledge of relevant Quality System and SOP procedures. Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and Regulatory standards.
• Advanced understanding of corporate documentation standards (SOP) and the interrelationship of SOPs and the functional areas.
• Ability to work independently on complex assignments and exercise sound judgment under minimal supervision.
• Ability to analyze non-conformance issues, recommend corrective action, and ensure compliance with company and Regulatory requirements.
• Ability to act independently and determine methods and strategies for addressing and documenting issues during product testing.
• Demonstrated strong leadership and communication skills.
• Ability to establish strong working relationships and work collaboratively in a team environment.
• Background in handling OOS, retest, and stability testing.
• Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment.

Skills

• Analytical method development and troubleshooting
• Quality systems and CAPA management
• Regulatory compliance and GMP fundamentals
• Data analysis and interpretation
• Communication and cross-functional collaboration

Education

• BS in Chemistry, Biology, Biochemistry, or a closely related scientific field

Additional Requirements

• Visual acuity screening and periodic re-testing for QC personnel (as part of job requirements)