Mount Laurel NJ
Summary: The Microbiologist completes and manages all microbiology and environmental monitoring testing in a pharmaceutical manufacturing and compounding environment. Commensurate with experience, medical/dental, holiday and paid time off after successfully completing introductory period, 401k.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Analyzes environmental monitoring and microbiological trends.
Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls.
Proficient in finished product and raw material testing (sterility, endotoxin).
Prepare and present technical microbiology and sterility assurance investigative and trend reports to management.
Formulate microbiology or sterility assurance recommendations for disposition or other actions related to process deviation or product complaints investigations.
Perform, lead, and schedule routine analysis of finished product, raw material or environmental samples according to established specifications and procedures
Performs technical review of test results for completeness and compliance to cGMP’s to ensure that documentation, controls and traceability are in place to maintain integrity.
Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities.
Prepares and reviews preparation of media, reagents, test samples and equipment as required.
Proficient in Environmental Monitoring techniques.
Proficient in Microbial Identification
Understands and demonstrates aseptic technique.
Support audits by regulatory agencies, such as FDA, BOP, and DEA.
B.S. degree in Microbiology
3 + years experience in Pharmaceutical/medical device industry
Knowledge of good analytical and laboratory techniques, pharmacy preparations, cGMP’s, GLP’s, SOP’s, USP and FDA requirements
Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls
Must exhibit good analytical, writing (GDP), interpersonal, and organizational skills
Must be able to meet deadlines
Must have the ability to demonstrate leadership skills
Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
Must exhibit strong computer skill including but not limited to software packages supporting statistical data analysis, word processing, and project management programs
Must have the ability to work in a fast past environment
Must exhibit excellent customer service and verbal communication skills
Must exhibit excellent problem resolution skills
Must be able to work independently, as well as part of a team
Must exhibit punctuality and low absenteeism
Must be able to sit, stand, reach and walk for prolonged periods of time
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.