Supervisor - CCS Quality Control

** Responsibilities*
* The Quality Control Supervisor is responsible for coordinating and supervising the daily product QC and environmental testing activities related to cell therapy manufacturing in a GMP and GTP compliant facility. The primary responsibilities of this role are focused on the analytical and/or microbial testing in place to support the manufacturing of aseptically processed cell therapy products. Secondary responsibilities of this role will include providing technical leadership, daily oversight, and subject matter expertise in GXP based testing.

This position does not perform or supervise CLIA or NYS CLEP regulated testing.

+ Provides the analytical and/or microbiological expertise, leadership, and guidance to ensure operations and staff implement appropriate microbial controls to meet regulatory requirements.

+ Provides expertise to support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and testing.

+ Leads investigations for out-of-specification test results, corrective actions, and verification of effectiveness.

+ Leads collaboration to develop and implement process improvement strategies.

+ Train, supervise, and mentor personnel to develop a strong team of highly skilled professionals responsible for conducting analytical and/or microbial testing.

+ Coordinate and maintain proficiency testing in conjunction with the Medical Lab Director for relevant QC testing.

+ Ensures regulatory and accreditation compliance in conjunction with the lab management including FDA, NYSDOH, AABB, and FACT as applicable.

+ Oversee the technical transfer, qualification, and validation of QC Analytical test methods.

+ Support product stability programs including generation of stability protocols, execution of stability testing, and generation of stability reports.

+ Reviews/audits documentation to ensure processes are performed and documented as directed by standard operating procedures.

+ Develops, reviews, and/or approves procedures, forms, protocols, and reports in support of manufacturing and testing activities.

+ Reviews and maintains an adequate supply inventory.

+ Establish positive working relationships with internal and cross-functional teams.

+ Participate in Continuing Education activities. Completes hours required by governmental agencies and/or accreditation organizations.

+ Responsible for the appropriate use of laboratory reagents, laboratory equipment, and other resources.

+ Assist in evaluating new technologies, assays, and clinical research protocols.

+ Assist in conducting data analysis and preparing reports.

+ Responsible for keeping individual and staff training requirements up to date.

+ Any related duties as assigned.

** Qualifications*
* *
* Education:

*
* + Bachelor's or higher degree from a program with a major in biology, chemistry, clinical laboratory technology, or physical sciences.

*
* Experience:

*
* + If bachelor's degree, at least four years of pertinent laboratory experience.

+ If master's degree with a major in one of the chemical, physical or biological sciences, has at least two years of pertinent laboratory experience.

** Knowledge:*
* + Demonstrate detailed understanding of applicable scientific principles and theories used in the quality control of analytical and microbial testing.

+ Knowledge of GTP, GMP, OSHA (including biosafety), FACT, and FDA regulations.

+ Knowledge of hematology analysis, flow cytometry, PCR, potency assays, endotoxin, colony forming unit assays, microscopy, gram stain, sterility, and environmental monitoring.

+ Experienced or knowledgeable in working in a regulated cGMP environment.

+ Experienced or knowledgeable equipment qualification, software validation, and analytical method transfer/verification/validation.

*
* Skills:

*
* + Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.

+ Excellent verbal and written communication skills.

+ Proficiency in computer systems and Microsoft Office suite.

+ Must be able to access, navigate and work in a GTP, GMP, and/or cleanroom environment.

+ Plan, organize, and execute protocols under minimal supervision following cGMP guidelines.

+ Maintain accurate and detailed documentation according to regulatory guidelines.

+ Periodically present results and summarize progress to team members.

** Abilities:*
* + Ability to work some irregular hours, including evenings or weekends, depending on workload.

+ Ability to…