Supervisor Quality Control Technicians MTF

Musculoskeletal Transplant Foundation•Edison, NJ

About The Position

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities. Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles. Supervise QA Technicians and other QA staff, as assigned, in performance of daily Quality Assurance functions. This includes ensuring that the daily, weekly and monthly quality functions are completed for environmental monitoring, microbiological sample preparation, incoming material inspections and nonconformance activities. Ensures that all related tasks and inspections are performed as per MTF procedures and applicable regulatory requirements. Acts as the subject matter expert for activities and projects involved with Quality Assurance. Monday-Friday 8am-4pm Salary Range: $80,368.60/Yr.

Requirements

Bachelor’s Degree , Biology or Life Sciences
Three years Quality Assurance experience in a GMP or FDA regulated industry.
At least two years experience as a supervisor or team leader.
Must be able to maintain qualification as per the gowning and gloving procedure for entrance into the cleanroom environment.
Must be proficient in data entry, Microsoft Outlook, Word, and Excel.
Must exhibit attention to detail, critical thinking, problem-solving, and effective communication skills.
Must be able to work with Quality inspectors in addition to internal and external auditors.
Must be able to supervise employees in a fast paced environment.
Must be physically able to don cleanroom apparel and perform physical activities and operate equipment in the cleanroom environment.
Minimal travel required – inter-facility, training purposes, team meetings, supplier inspections

Nice To Haves

MS in science filed and/or quality assurance.
5 years Quality Assurance experience in a GMP or FDA regulated industry.
At least 4 years experience as a supervisor or team leader.
Microbiology knowledge
Knowledge of statistical techniques

Responsibilities

Oversees and supervises the daily routines of the Quality Assurance technician and specialist staff.
Is responsible for all human resources activities including but not limited to staffing and recruiting, training and development, performance management and disciplinary actions, and merit and bonus recommendations.
Observes and actively manages personnel to ensure required tasks are completed accurately and on time.
Investigates, performs root cause analysis, provides evidence, and verification of effectiveness of actions related to NCRs, CAPA, audit findings, improvements and trends requiring action of all activities associated with the QA release functions above.
Reviews and compiles environmental data including water results, viable testing, non-viable testing, and trend data for the ISO controlled areas and other environmentally monitored areas.
Interacts with internal MTF departments and Business Units and contract laboratories to organize, review and analyze data pertaining to the Sampling with MTF procedures, product specifications, and applicable regulatory requirements.
Coordinates QA shutdown activities and ensure these tasks are completed accurately and timely.
Schedules coverage for QA personnel throughout the week, weekends, holidays and shutdowns, as well as adjusts workloads to meet the demands of the Business Units.
Solicits feedback about the current process to identify and recommend process improvements.
Monitors the progress of work and oversees completion of special projects which are specific to environmental monitoring, incoming inspection, and shipment of samples for testing.
May assist in supporting and the completion of validations.
Represents the Quality Assurance department in projects pertaining to environmental monitoring, incoming raw material inspections, and shipment of samples for testing.
Facilitates problem solving and communication between departments to meet QA specifications and standards.
Writes and revises SOPs, flowcharts, and forms associated with Quality Assurance responsibilities and procedures.
Ensures staff competence in performing new tasks.
Evaluates personnel for competency on an annual basis as a minimal requirement.
Tracks and approves Quality Assurance invoices for testing performed by contract facilities.
Provides feedback for staffing needs, evaluates candidates, and recommends appropriate personnel to fill open QA positions.
Oversees and monitors the gowning qualification data for Business Units.
Performs additional duties as assigned.