United States onlyMTF 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.
Performs and documents daily, weekly, and monthly environmental monitoring activities within a strict ISO Class clean room environment in accordance with MTF procedure and Work Instructions, applicable US FDA regulations, Australian TGA Regulations, AATB Standards and other applicable governmental regulations. Environmental sampling results are used to determine clean room are operating in accordance to written specifications and determining the final release of processed tissues/devices. Environmental sampling is extremely time sensitive due to the biologic nature of the samples obtained. Develops technical raw material specifications for assessing and approving incoming supplies and materials used for the aseptic processing and testing. Performs technical review and approval of certificates of conformance for critical incoming processing supplies, laboratories supplies and materials to ensure compliance to established specifications. Packages, documents, and ships required samples to internal and external laboratories for testing. Interfaces with external calibration vendors to schedule visits and maintain calibration records to comply with MTF policy and regulatory requirements. Schedules and packages equipment to be sent off site for calibrations and maintenance. Manages the paper as well as the electronic database records in Blue Mountain Regulatory Asset Management (BRAM) system.
Tuesday Night- Saturday Morning 10pm to 6am
Responsibilities
- Operates critical, highly specialized air sampling equipment within a strict aseptic clean room environment and ensures equipment is working as intended and is appropriately calibrated. Operation of sampling equipment and obtaining environmental samples requires a high degree of dexterity while aseptically gowned and gloved. Maintains strict aseptic technique at all times within an ISO Class aseptic clean room processing environment to prevent contamination and cross contamination of the environment and the tissue/ device.
- Performs critical, time sensitive environmental sampling of the MTF clean room aseptic processing facility including, but not limited to; non-viable air sampling, viable air and surface sampling, water and LAL sampling, and nitrogen system testing per MTF procedure and work instructions.
- Non-viable sample results are available immediately. If results are not meeting MTF specification requirements, QC technician assesses the clean room environment, completes appropriate documentation, decides if immediate correction action can be implemented, and notifies the appropriate required individuals. Discusses with QC management and assists with implementing additional corrective actions at a later time if required.
- Viable testing samples, water and LAL samples, and nitrogen testing samples are taken as per procedure. QC technician completes the appropriate documentation, packages the samples properly, and ships the samples to the appropriate testing laboratory in a timely manner. When result is available and not meeting MTF specification requirements, discusses with QC management and assists with implementing corrective actions.
- Assists in providing weekly or monthly trending and reporting of environmental testing data.
- Schedules and documents calibration and maintenance for clean room and laboratory equipment
- Inputs calibration data into the BRAM database and identifies when NCRs need to be generated.
- Monitors calibration files and provides monthly due and past due lists to equipment owners.
- Generates any necessary nonconformance reports, performs the necessary investigations, directs any necessary actions, completes the required documentation, and follows up to ensure the nonconformance is resolved in a timely manner if requested by QC management.
- Develops technical raw material specifications for assessing and approving incoming supplies and materials used for the aseptic processing and testing.
- Performs technical review and approval of certificates of conformance for critical incoming processing supplies and laboratories supplies and materials to ensure compliance to established specifications. Packages, documents, and ships required samples to internal and external laboratories for testing.
- Generates any necessary non conformance reports, performs the necessary investigations, directs any necessary actions, completes the required documentation, and follows up to ensure the nonconformance is resolved in a timely manner.
- Documents, reconciles, packages and ships samples to appropriate testing facility in a timely manner. These samples are including, but not limited to: sterility, bioburden, transport solution, LAL, water, viable air and surface, and finger touch plates. Enters appropriate information regarding the shipment of samples in the Quality Donor Data System (QDDS) as required. Follows up with the internal and external laboratories regarding any issues with receipt of the sample or paperwork discrepancies.
- Assists in the completion of environmental validations by performing environmental monitoring and providing information for validation reports. This involves procedures or specialized testing equipment that may not be included in current MTF work instructions.
- Non-viable sample results are available immediately using specialized testing equipment. If results are not meeting MTF specification requirements, QC technician assesses the environment, completes appropriate documentation, decides if immediate correction action can be implemented, and notifies the appropriate required individuals. Discusses with Quality Engineering and assists with implementing additional corrective actions.
- Viable testing samples are taken as per procedure. QC technician completes the appropriate documentation, packages the samples properly, and ships the samples to the appropriate testing laboratory in a timely manner. When result is available and not meeting MTF specification requirements, discusses with Quality Engineering and assists with implementing corrective actions.
- Acquires, incubates, reads and documents results for autoclave bio-indicator vials, if required. Generates any necessary nonconformance reports if required, performs the necessary investigations, directs any necessary actions, completes the required documentation, and follows up to ensure the nonconformance is resolved in a timely manner.
- Provides input and recommendations for updates to OPs, Wis, and forms.
- Performs additional duties, as assigned.
- 1 year of experience in GMP or FDA regulated industry
- Must be able to maintain qualification as per the gowning and gloving procedure for entrance into the clean room environment
- Excellent manual dexterity skills to operate equipment and to obtain other environmental samples
- Must exhibit attention to detail, critical thinking, problem-solving and effective communication skills
- Must be proficient in data entry, Microsoft Outlook, Word, and Excel.
- Must be able to maintain strict aseptic technique at all times within an active ISO Class aseptic clean room processing environment to prevent contamination and cross contamination of the environment and environmental samples.
At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.
- 4 weeks Paid Time Off (PTO)
- Paid Holidays
- Medical, Dental, Vision Insurance and Prescription Drug Insurance
- 401K plan with company match
- Short & Long Term Disability
- Life & Accidental Death Insurance
- Tuition Reimbursement
- Health Care/Dependent Care Flexible Spending Accounts
- Adoption Assistance
- Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
- Sword Health (at home Physical Therapy)
