Description:

Position Overview:

Provides moderately complex analyses in a microbiological environment within defined procedures and practices. Performs microbiological methods for moderately complex testing on raw materials samples stability production intermediates environmental monitoring sterility tests growth promotion microbial limits tests and/or method development testing. Supports internal development and/or manufacturing operations. Makes detailed observations reviews documents and communicates test results recommends solutions.

Primary Responsibilities:

- Conducts moderately complex microbiological testing of pharmaceutical raw materials packaging components finished products and stability samples by internally developed and compendial test methods.

- Completes Microbiology Method Development Protocols that are written internally by Microbiology Management and signed off with QA and Client approval.

- Recognizes and reports out-of-specification or unexpected results and non-routine product problems recommends solutions.

- Maintains and troubleshoots analytical instrumentation as needed.

- Clearly and accurately communicates the results of work by documenting the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.

- Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments corporate sites agencies and clients.

- Writes SOPs and other instructional documents.

- Cleans and organizes work area instrumentation and testing materials.

- Performs all duties in strict compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines.

COMPETENCIES:

Experience with Good Manufacturing Practices GMP and Good Laboratory Practices GLP. Proficient in the understanding and application of aseptic technique environmental monitoring and identification of microorganisms. Effective written and interpersonal skills with the ability to interact with Auditors if there is a need. Strong proficiency in Microsoft Office Suite Word Excel and Power Point. Ability to multitask by working on multiple projects simultaneously and able to adapt and change priorities when business needs demand a shift in priority. Ability to work weekends when needed based on business needs.

REQUIRED:

- Good knowledge and understanding of analytical instrumental technologies.

- Good knowledge of qualitative and quantitative microbiological analysis.

- Good knowledge of quality and regulatory requirements in the pharmaceutical industry including pharmaceutical GMPs..

- Good problem solving skills and logical approach to solving scientific problems.

- Proficiency with Environmental Monitoring Microbial Limits Testing Growth Promotion Media Quality Control and Method Development preferred.

- Ability to read analyze and interpret technical procedures and governmental regulations.

- Ability to write standard operating procedures simple protocols and reports.

- Ability to apply mathematical operations to such tasks as determination of test reliability analysis of variance and correlation techniques.

Skills:

Biology, Molecular biology, Laboratory, method development, Analytic, Process development, GMP, microbiological, microbiology laboratory, Microbiology, Biochemistry, Assay development, Assay, Pcr, Elisa, Cell culture

Top Skills Details:

Biology,Molecular biology,Laboratory,method development,Analytic,Process development,GMP,microbiological,microbiology laboratory,Microbiology

Additional Skills & Qualifications:

Education:

- Bachelors degree in physical science preferably in Microbiology Biology or Natural Science.

Required Experience:

Top 3 skills:

1. Physically able to stand and move around large 40 acre warehouse for 6-8 hours per day.

2. Keen attention to detail.

3. Familiar with documentation practices

- Typically requires a minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials finished products or microbiological samples.

- Experience with aseptic technique and common office software.

Nice to have: Familiarity with aseptic processes.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.