Location: Edison, NJ
The Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. We’re comprised of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. MTF also has two subsidiaries, Statline and IIAM.
More Info and Application
Job Description
Performs and documents daily, weekly, and monthly environmental monitoring activities. Packages, documents, and ships required samples to internal and external laboratories for testing. Inspects, documents, and releases incoming raw material shipments.
Performs job responsibilities as per MTF procedures and applicable regulatory requirements.
Responsibilities:
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Performs environmental monitoring of the MTF process facility including, but not limited to; non-viable air sampling, viable air and surface sampling, water and LAL sampling, and nitrogen system testing.
1.1 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 QA management and assists with implementing additional corrective actions at a later time if required.
1.2 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.
1.3 Ensures that specialized QA testing equipments has a current calibration date and the equipment is working as intended before completing environmental testing.
1.4 May provide weekly or monthly trending and reporting of environmental testing data.
1.5 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.
2. 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.
3. Inspects, documents, and releases incoming raw materials used in the processing, labeling, and shipping of tissue/devices at the MTF facility. 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.
4. 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.
4.1 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.
4.2 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.
5. 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.
Performs job responsibilities as per MTF procedures and applicable regulatory requirements.
Responsibilities:
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Performs environmental monitoring of the MTF process facility including, but not limited to; non-viable air sampling, viable air and surface sampling, water and LAL sampling, and nitrogen system testing.
1.1 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 QA management and assists with implementing additional corrective actions at a later time if required.
1.2 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.
1.3 Ensures that specialized QA testing equipments has a current calibration date and the equipment is working as intended before completing environmental testing.
1.4 May provide weekly or monthly trending and reporting of environmental testing data.
1.5 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.
2. 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.
3. Inspects, documents, and releases incoming raw materials used in the processing, labeling, and shipping of tissue/devices at the MTF facility. 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.
4. 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.
4.1 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.
4.2 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.
5. 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.
Job Requirements
Education:
High school diploma
Preferred: College coursework in biology, microbiology, or life sciences
Experience:
One to two years experience in GMP or FDA regulated industry.
Preferred: One to two years experience working in ISO controlled areas
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.
Must be proficient in data entry, Microsoft Outlook, Word, and Excel. Must exhibit attention to detail, critical thinking, problem-solving, and effective communication skills.
Work Environment:
Cleanroom and office environment
Physical Demands:
(if applicable)
Must be able to stand for long periods of time and work 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.
High school diploma
Preferred: College coursework in biology, microbiology, or life sciences
Experience:
One to two years experience in GMP or FDA regulated industry.
Preferred: One to two years experience working in ISO controlled areas
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.
Must be proficient in data entry, Microsoft Outlook, Word, and Excel. Must exhibit attention to detail, critical thinking, problem-solving, and effective communication skills.
Work Environment:
Cleanroom and office environment
Physical Demands:
(if applicable)
Must be able to stand for long periods of time and work 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.
Company Overview
The Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. We’re comprised of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. MTF also has two subsidiaries, Statline and IIAM.
More Info and Application
Posts
0 comments:
Post a Comment