Qc Microbiology Associate Ii Jobs

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

Learn new skills and enjoy new experiences in an engaging and safe environment

Communicates issues or challenges to senior staff and/or management

learn new skills and enjoy new experiences in an engaging and safe environment

Able to apply prior knowledge to accurately interpret structural data.

Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.

Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed

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.

• Advance technical writing skills and ability to effectively communicate with peers and department management.

• Communicate effectively with management regarding task completion, roadblocks, and needs.

• May train on additional test methods and provide support to a broader spectrum of testing responsibilities.

• Demonstrated experience with basic laboratory techniques and laboratory safety practices.

• Knowledge of regulatory standards as they apply to GMP laboratories is preferred.

• Experience with LIMS and ELN computer applications is preferred.

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

Experience with IR and AA instrumentation

H.P.L.C. and G.C. instrumentation experience

Catalent offers rewarding opportunities to further your career!

Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.

Maintains cultures according to ATCC and departmental Standard Operating Procedures.

Performs identification of microorganisms using techniques such as API, Gram Stain, etc. Prepares reagents, standards, Medias, etc. needed for analysis.

5-7 years of related experience. Lab experience required. Experience in Biologics/chemistry, GMP regulated environment preferred. .

Education Assistance Policy - $5,000 per year for all employees

What can we offer you?

Primary responsibility for the day-to-day activities in the QC Chemistry laboratory in support of product release testing

Scientific/technical contributor on cross-functional projects related to all QC Chemistry activities and Bioassay development

Interact and coordinate with Manufacturing on a daily basis.

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

Develop advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.

Assist in critical reagent qualification/re-qualification, in compendia methods and other analytical method qualification/validation/transfer.

1+ years industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience

We are looking for professionals with these required skills to achieve our goals:

Conduct routine non-compendial, biochemistry, analytical testing for in-process, release, and stability drug product samples per SOP.

Analytical methods include HPLC, Capillary Electrophoresis, SoloVPE and others.

EDUCATION AND EXPERIENCE YOU’LL BRING

an equivalent combination of education and work experience

At Abbott, you can have a good job that can grow into a great career. We offer:

Learn more about our benefits that add real value to your life to help you live fully

Handle discrepant materials per the documented disposition and document activities in the appropriate systems or paperwork.

Performs simple statistical analysis through the collection and input of data into software applications or manual calculations.

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.

Advance technical writing skills and ability to effectively communicate with peers and department management

0-3+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in regulated environment

0-3 years experience in Biopharmaceutical field

Experience with basic laboratory techniques and laboratory safety practices

Knowledge of regulatory standards as they apply to GMP laboratories is preferred

Experience with LIMS and ELN computer applications is preferred

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

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.

Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

Excellent effective written and verbal communication and interpersonal skills

Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA