Quality Control Technician JESS

MTF Biologics; Jessup (Lackawanna County); On-site; USD 50,000 - 65,000; Full time

Job summary

MTF Biologics is seeking an Entry Level Quality Assurance Technician to perform environmental monitoring and sampling in a strict ISO Class clean room. This role involves maintaining strict aseptic techniques, documenting sampling results, and ensuring compliance with organizational and regulatory standards. Join us in positively impacting lives through dedicated work in tissue processing.

Benefits

4 weeks Paid Time Off (PTO)

Paid Holidays

Medical, Dental, Vision Insurance

401K plan with company match

Tuition Reimbursement

Short & Long Term Disability

Qualifications

• 1 year of experience in GMP or FDA regulated industry.
• Must maintain qualification for clean room procedures.
• Proficient in data entry and critical thinking.

Responsibilities

• Operates air sampling equipment in an aseptic clean room environment.
• Performs critical environmental sampling and documentation.
• Generates nonconformance reports as needed.

Skills

Attention to detail

Critical thinking

Problem-solving

Effective communication

Manual dexterity

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

20 hours ago Be among the first 25 applicants

Overview

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.

Overview

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.

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.

Sunday to Thursday 7:30am to 3:30pm

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.
  
  

Qualifications

• 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.
  
  

Benefits Information

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)

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Science, and Health Care Provider

• Industries

  Medical Equipment Manufacturing, Biotechnology Research, and Hospitals and Health Care

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