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Musculoskeletal Transplant Foundation Quality Assurance Technician in Edison, New Jersey

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. Enivronmental 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 and laboratories supplies and materials to ensure compliance to established specifications. Packages, documents, and ships required samples to internal and external laboratories for testing.

  • Operates critical, highly specialized air sampling equipment within a strict aspeptic 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 aspetically 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 senstive 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.

2.1 Non-viable sample results are available immediately. If results are not meeting MTF specification requirements, QA 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 QA management and assists with implementing additional corrective actions at a later time if required.2.2 Viable testing samples, water and LAL samples, and nitrogen testing samples are taken as per procedure. QA 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 QA management and assists with implementing corrective actions.2.3 Assists in providing weekly or monthly trending and reporting of environmental testing data.2.4 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 QA 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 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.

  • 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.

7.1 Non-viable sample results are available immediately using specialized testing equipment. If results are not meeting MTF specification requirements, QA 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.7.2 Viable testing samples are taken as per procedure. QA 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.

MINIMUM JOB REQUIREMENTS

Education:

High school diploma

Experience:

One to two years experience in GMP or FDA regulated industry.

Specific Licenses and/or Certifications:

None

Specialized Knowledge, Skill, and Abilities*:

Must be able to maintain qualification as per the gowning and gloving procedure for entrance into the cleanroom environment.

Excellent manual dexterity skills to operate equipment and to obtain other environmental samples while aseptically gowned a gloved.

Must exhibit attention to detail, critical thinking, problem-solving and effective communication skills.

Must be proficient in data entry, Microsoft Outlook, Word, and Excel.

Work Environment:

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.

Environmental sampling is extremely time sensitive and time critical. Sampling delays or errors in sampling may cause costly delays in turnover of clean rooms to processing personnel and delays in the final release of tissues.

Physical Demands:

(if applicable)

Must be able to work within small, enclosed aseptic clean room processing environments.

Must be able to stand for long periods of time and work while aseptically gowned and gloved for up to four hours without a break in a cleanroom environment.

Must be able to lift 50 pounds.

Must be able to work extensive hours including nights, weekends, and holidays as per assigned schedule, unexpected events, shutdown activities, and as business needs dictate.

PREFERRED QUALIFICATIONS

Education:

College coursework in biology, microbiology, or life sciences preferred.

Experience:

One to two years experience working in ISO controlled areas.

Specific Licenses and/or Certifications:

CTBS

Specialized Knowledge, Skill, and Abilities:

Previous clean room experience

Shift: 1st Shift

ID: 2020-4562

External Company Name: Musculoskeletal Transplant Foundation

External Company URL: http://www.mtf.org/

Street: 125 May St

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