Qc Microbiology Assoc I 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.

Required Skills, Knowledge, and Abilities

Effective interpersonal skills when working with others.

Ability to follow the specifics of the chart order.

Input data into computer programs.

Ability to operate, perform user maintenance, and troubleshoot high speed scanners.

Ability to pay attention to detail to ensure documents for the correct patient go in the chart.

Manages the quality control activities of an organization.

Requires breadth of professional field and industry knowledge.

Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.

Ensures budgets, schedules, and performance requirements are met.

Judgement is required in resolving complex problems based on experience.

10-12 years related experience required.

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.

Participating in the daily activities and work assignments of research staff.

Planning and coordinating complex research experiments following standard operating procedures.

Working with Principal Investigator(s) to coordinate project activities and establish appropriate reporting procedures.

Contributing to scientific analysis and interpretation of projects.

Establishing and maintaining quality control measures for assigned project operations.

Making modifications to research procedures in collaboration with the Principal Investigator(s) and contributing to the writing of SOPs and protocols.

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.

Required Skills, Knowledge, and Abilities

Effective interpersonal skills when working with others.

Ability to follow the specifics of the chart order.

Input data into computer programs.

Ability to operate, perform user maintenance, and troubleshoot high speed scanners.

Ability to pay attention to detail to ensure documents for the correct patient go in the chart.

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.

Maintain training, qualification, and certification records for QC Inspectors

Provide Management with an information on all welders with a weld reject rate >5% .

Assist the Shop Management Team in resolving production welding problems

Work with corporate to maintain Quality Manual to meet the applicable ASME Code requirements.

Prepare QC Checklists for each job that list the specific QC/NDE requirements required for the job

Investigate Client Non-Conformance reports for cause and provide information to the Project Manager

Verify special processes and the relevant workers’ qualifications.

A working knowledge of BS/IEC/ISO/API/ATEX/EEMUA codes and standards relating to electrical and instrumentation work

Working knowledge of construction standards, codes of practice and regulations/legislation relating to electrical and instrumentation work

Knowledge of safety legislation and regulations

Hazardous Area installation and inspection experience is an advantage

Issues the relevant Quality Records and, when necessary, writes and sends to QC Supervisor non-conformances reports.

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

Knowledge of LIMS, TrackWise, Metasys.

Bachelor’s Degree or equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)

Travel Requirements: 0 to 10%

Collect, calculate, and interpret test results.

Enter and report test results.

Take ownership and execute revisions for SOPs and ATP's related to testing programs, laboratory operations and/or equipment operation.