QC Microbiology Group Leader

Job Description

Position Responsibilities :

The QC Microbiologists are responsible for leading the key operational aspects of the QC Microbiology laboratory at our client site.

These positions perform and train others on the microbial testing of all in -process drug substance, drug product, EM / UM, and raw materials samples.

These positions primarily work independently with minimal supervision as needed, acting in consultation with client management for all decisions.

This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory so there will be flexibility in job roles.

There may be the opportunity to write or assist with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting client management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

Key Responsibilities :

• Ensure adherence to highest quality and efficiency standards in laboratory operations. Ensure cross training initiative are in place and followed.
• Lead by example. Demonstrate by words and actions what it is to be a successful ELLI PSS employee. Demonstrate willing to do what is necessary for the program to be successful.

Demonstrate through word and actions that we are part of the team.

• Foster morale and teamwork. Ensure the reward and recognition programs are utilized to the fullest. Ensure systems are implemented at the site to foster team morale.
• Develop and maintain effective, trusting work and customer relationships. Build loyal customer relationships. Meet with Client’s on a regular basis.
• Lead team, schedule, and train employees in client environment
• Ensure adherence to highest quality and efficiency standards in laboratory operations
• Ensure coverage and performance
• Foster morale and teamwork
• Performing advanced lab testing and support for all laboratory assays for all samples
• Leading sample collection and managing sample logistics for testing
• Supporting testing for all qualification and study directed testing
• Leading sterility testing
• Reviewing intermediate lab testing results
• Acting as qualified trainer and SME of at least one test
• Troubleshooting complex assays
• Assisting with writing of documents. Reviews and edits documents
• Supports investigation of routine OOS assays and events
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes

Qualifications

• BS with 5+ years of experience within Microbiology, Biochemistry, Biology or MS with 3+ years of experience within Microbiology, Biochemistry, Biology
• Leadership experience
• Experience with aseptic production & support
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
• 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
• Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
• Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
• Strong leadership, initiative, and teambuilding skills
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Additional Information

Position is Full Time, First Shift - some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Holly Springs, NC are encouraged to apply.

What we offer :

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.