Catalent Hiring for Supervisor, QC Microbiology job in Harmans Full Time

The Supervisor, QC is responsible for leading Microbiologist as well as overseeing the end-to-end contamination control and sterility assurance practices for Catalent’s aseptic production process. This position will lead the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, compliance to regulations and standard in the subject of sterility assurance and contamination control.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Shift: 2nd Shift (Monday – Friday 4pm – 12:30am)

The Role

• Supervise the day to day operations in assigned area of the QC Microbiology department.
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
• Build effective teams that apply their diverse skills and perspectives to achieve common goals.
• Provide lead audit support during regulatory and customer audits
• Always maintain the Microbiology lab in Audit Readiness.
• Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager.
• Communicate effectively with QC peers, cross-functional peers and management.
• Lead troubleshooting and problem solving that may come up in the day to day operation of the department.
• Approve revisions and creations of controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects.
• Lead investigations, Deviations, Change controls & CAPAs associated with Microbiological testing.
• Support and lead data trending and tracking of results.
• Assist QC Manager/Supervisor with GMP and safety training of Quality Control staff
• Provide Microbiological instrumentation training to all new Microbiologists.
• Provide training to all Microbiologist on new and existing revisions to Lab SOPs, protocols, work instructions and Test Methods.
• Eligible to apply for the Qualified Trainer (QT) Program.
• Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration.

The Candidate

• Bachelor in a Microbiology, Molecular Biology, Biological sciences, or related discipline with 8-10 years of experience working in a cGMP QC laboratory.

Or

• Masters’ in a Microbiology, Molecular Biology, Biological sciences or related discipline with 6-8 years of experience working in a cGMP QC laboratory.

Or

• 2-4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
• Strong experience working in cGMP Quality Control.
• Experience in cGMP environment and experience with Quality Tools such as 6M, Ishikawa and Root Cause Analysis, USP, HACCP, technical writing skills and Lean lab.
• Proficient in test method development and validation of various bioassay and microbiological or chemical test attributes.
• Demonstrate strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.
• Demonstrated ability to investigate and identify causes of suspect laboratory results.
• Strong knowledge of analytical and/or microbiological method design.
• Strong technical writing skills and use of Microsoft Office products.
• Strong attention to detail and strong organizational skills.
• Strong verbal communication skills with outside contract laboratories.
• Ability to succeed in a team-oriented environment under very dynamic conditions.
• Must have the ability to work an available set shift.

• Have hands on experiences in the areas of: Bacterial endotoxin, Bioburden, Microbial Identification, Growth promotions, Environmental monitoring, Utilities monitoring, BIs and routine/non routine Microbiological projects.

• Experience in LIMS, MODA and/or other electronic documentation/data management system preferred

Position Benefits

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross functional exposure to other areas of within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 152 hours of paid time off annually + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

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