Qc Microbiology Associate Ii Jobs in Texas

Position requires a BS in Chemistry with 5-7+ years’ experience as a QC Manager in a pharmaceutical or Biotechnology organization.

Experience leading teams of QC professionals is required.

The position requires experience working in a cGMP environment and experience with documentation and implementation of quality systems.

Provides leadership and communication on all quality control matters with both internal and external groups and customers.

Assures the utilization of appropriate industry/regulatory standards and analytical tools to investigate any questionable results and develops/implements appropriate CAPA.

Develops and implements actions aimed at continuous improvement for the laboratory environment.

Experience with organic structural analysis and its interpretation in petrological and mineralogical context.

Experience in UV flight instrument operation and development.

This position requires the following qualifications:

The following qualifications are preferred:

For further benefits information click Benefits and Perks

PhD in geomicrobiology, or a related field.

Additional responsibilities as assigned by Quality management.

Assist with management of retention materials, laboratory equipment maintenance and repair, and other projects as directed.

Knowledge of basic validation, equipment calibration, equipment maintenance and change requirements

Effectively manage multiple responsibilities and complete tasks on schedule

Position requires occasional overtime as designated by Operations/Quality management. Overtime duties may be outside of direct area of responsibility.

Related experience should be in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device Quality Assurance role

Participates in quality management system requirements including following departmental work instructions, creating records, document control, and addressing corrective and preventative actions

Equipment validation, qualification, calibration, and preventative maintenance

Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements

Associate degree and 1-2 years related experience.

OR bachelor's degree and 1-2 years related experience.

Ensure laboratory compliance with applicable regulations.

0-2 years of relevant laboratory experience or experience in a cGMP/FDA regulated industry preferred.

Demonstrated knowledge in Microbiology and aseptic techniques required.

Detail-oriented with strong written and verbal communication skills.

Primary responsibility entails processing samples from the cleanrooms, including non-viable particulate, viable air and surface sampling, and personnel monitoring.

Performs growth promotion of raw materials.

Performs Gram stain and classic microbiology techniques.

Specific expertise, skills, and knowledge within microbiology gained through education and/or experience.

Strong communication, documentation, and time management skills.

Reports out of specification, out of trend, and abnormal results to microbiology department management.

Aids the Sample Management team, as apparent or needed.

Must have strong organizational skills and be able to manage multiple projects or assignments at one time.

Additional work duties or responsibilities as evident or required.

Collect Utility Monitoring Samples (RODI/WFI) routinely and for qualification of systems.

Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.

Good attention to detail and ability to utilize problem solving/trouble shooting skills.

Demonstrated written and oral communication skills.

Strong organization and analytical skills.

Experience prolonged standing, some bending, stooping, and stretching.

Prepares and distributes daily and weekly quality control reports for management.

Monitors, evaluates and coordinates with sales and plant management on products returned from customers.

Works with USDA inspection, grading personnel, and production supervisors to assure that pertinent requirements are being met.

Manages the implementation of the SIS program or other FSIS programs in the plant.

Investigates and responds to customer inquiries and complaints as directed by the Quality Control Manager and Division Manager.

Orders necessary supplies and materials and coordinates with Division Manager and Quality Control Manager in preparing the quality control budgets.

Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.

Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.

Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.

4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).

Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.

Excellent/Effective written and verbal communications skills