Qc Microbiology Assoc I Jobs in Sabine, Texas

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.

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.

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.

• Identify and implement manufacturing procedures intended to optimize existing processes and ensure compliance with regulatory requirements.

• Experience in flow assays a MUST

• Experience in bioassays is a plus

Introductory Experience in the use of scientific laboratory techniques, equipment and materials:

• Excellent documentation and communication skills.

• Consistent, dependable, and accurate in carrying out responsibilities

Education or experience in microbiology, math, and chemistry

Experience with GMP and GLP requirements

Experience testing natural products and ingredients

Experience with environmental and allergen testing

Experience using laboratory equipment and documentation systems

Experience writing reports and communicating results

Read test results and notify Lab Management of results that are out of specification;

Reporting and evaluating results and data entry using Labware (LIMS);

Knowledge of chemistry and analytical chemistry fundamentals as related to quality control;

Strong functional and technical skills, strong analytical instrumentation background in quality control and in a production environment;

Excellent written and oral communication skills;

Good organizational skills and great attention to detail;

Responsible for understanding and implementing the Food Safety and Quality Management System and related activities, including SQF standards:

Meet Skill Level Requirements as determined by Quality Leadership.

Off-site Co-Manufacturer and Supplier auditing skills.

Preferred education: Bachelor’s Degree in Food Science or science related college level courses.

Expected experience: 2+ years in a manufacturing environment, including employee training.

Excellent analytical skills with attention to detail and ability to demonstrate critical thinking.

o Assist with inventory management:

o Maintain all qualification and validation requirements for entering ISO classified area.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

o Technical experience with computer-controlled automation preferred.

o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

Perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles

Experience in a molecular biology laboratory preferred.

Experience with Sanger sequencing and/or Next Generation sequencing preferred

The essential requirements of the job include:

Act as primary analyst for routine and non-routine sequencing projects, including reaction preparation, analysis, and reporting

Support readiness of the sequencing lab through equipment maintenance, buffer preparation, materials planning and requests

Strong oral and written communication skills

In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology

Previous experience in aseptic manufacturing highly preferred

Positive attitude and strong interpersonal skills

Must be able to work at all NH PCI sites inclusive of remote locations

Achieve and maintain gown qualification for sterile environments.

Technical skills in microbiology to include, but not limited to aseptic technique, sterile gowning, and pipetting are required.

Excellent computer, documentation, communication, and organizational skills required.

Experience in cGMP environment preferred

Experience with sterility, mycoplasma, environmental monitoring, and water testing preferred.

Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities.

Strong oral and written communication skills

In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology

Previous experience in aseptic manufacturing highly preferred

Positive attitude and strong interpersonal skills

Must be able to work at all NH PCI sites inclusive of remote locations

Working knowledge of shop mathematics, and CATIA or blueprint reading and interpretation.

Perform conformity/first article inspections to ensure compliance with FAA approved procedures.

Ensure the proper use and storage of area tools and equipment.

Provide technical support to manufacturing personnel. .

Perform area inspections to ensure compliance with applicable standards and specifications. .

Participate in continuous improvement activities. .

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

May perform other duties as assigned by QC Micro Management.

Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.

Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.

Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed.

Strong preference for experience in the following:

Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices

Utilize a range of electronic systems such as LIMS and document/equipment management software.

Train on and maintain extensive knowledge of current regulatory requirements and relevant internal procedures.

Resolve routine and advanced problems by utilizing appropriate resources. Provide problem solving skills to lead and/or support investigations.

Perform Environmental Monitoring and utilities monitoring.

Perform bioburden, sterility, endotoxin and other routine and more advanced testing.

Perform routine QC testing in accordance with SOPs and cGMP guidelines. Minimal supervision.

Proven history of working in a fast-paced team environment, time management, and meet deadlines.

Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP requirements

Bachelor’s Degree in chemistry, biology, or microbiology with 0-3+ years’ relevant microbiology laboratory experience in Pharmaceutical/Biotech.

Excellent knowledge of Aseptic technique and common microbiological testing

Knowledge of relevant, compliance and guidance documents

Interpersonal skills and ability to contribute to the success of a team

Monitors project deliverables and timelines, notifies management when issues arise, and take corrective actions, as needed.

Bachelors degree required, or equivalent education and work experience

None required, 1 year of experience in project coordination preferred.

Develops and maintains a detailed project schedule which includes administrative tasks. Ensures adherence to deadlines.

Coordinates and leads assigned project activities ensuring that assignments are completed.

May develop reports and other deliverables as assigned.

Advanced organizational and time management skills.

Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.

Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Management (including Assessments and FMEA).

Advanced knowledge and understanding of industrial/pharmaceutical microbiology, aseptic manufacturing, environmental control, and monitoring, and compendial and rapid microbiology methods.

Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.

Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

Requires education equivalent to four years of high school

You’ll be DISRUPTIVE through these duties and responsibilities:

Consolidates orders based on pick slip number and type of order to be shipped or staged

Counts and packs product into a box

Labels box with box quantity and total order quantity

Utilize pallet jacks to move full pallets into the staging area

Demonstrated experience with the qualification/validation, knowledge of regulatory requirements, general knowledge of biopharm manufacturing process, audit experience.

Manages teamwork through good communication skills to administer personnel policies in accordance with site policies and procedures.

Demonstrated experience of leading others and coaching/mentoring skills

Knowledge of good documentation practices, cGMP, and GPS requirements

B.S/B.A. Degree with a minimum of 5 years post-degree laboratory, manufacturing, or quality control/assurance experience

Strong organizational and communication skills and attention to detail