Quality Control Microbiologist

Overview:

Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.

Job Description:

• Quality Control Microbiology – Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release.

POSITION SUMMARY

• This position is to support related QC Assay testing/validation for Inspire-01 project.

POSITION DUTIES & RESPONSIBILITIES

• Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility including protocol and report write up.
• Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
• Familiarities with all microbiological compendial methods for specific commercial products.
• Maintains records of method qualification/validation and other microbiological related methods.
• Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable.
• Collaborates effectively with Quality Assurance validation on the method validation approach.
• Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, revises SOP’s affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervision.

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• Minimum Education bachelor’s degree in microbiology or related science degree or technical field. Minimum Experience 2 years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.

Skill & Competency Requirements:

• (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Strong computer skills (Word, Excel, Access, PowerPoint).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervisio

Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)

• Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies).

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Job Types: Full-time, Contract

Pay: $30.00 - $31.00 per hour

Work setting:

• In-person

Application Question(s):

• How many years of experience do you have in microbiological method validation in the pharmaceutical or a related industry?
• Do you have experience working with biologics and manufacturing processes in a quality control microbiology testing laboratory?
• Have you conducted microbiological validation methods?
• Can you describe your experience with writing protocols and reports for microbiological method validation?
• Do you have any experience working in a cGMP environment?
• Do you have any knowledge of FDA, EMA and other international regulations?

Work Location: In person

Salary : $30 - $31