Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.
Overview of this Position:
The QC Supervisor - Microbiology - Technical Support is responsible for managing a team of microbiological scientists supporting internal and external projects. Provides guidance to solve complex microbiology problems. Oversees client projects simultaneously, while managing competing priorities, to effectively meet deadlines and commitments. Is an effective member of various cross-functional teams to drive and process improvements, budgetary decisions, business development initiatives, and other corporate programs. Communicates effectively across all levels of the organization and with external project teams. Serves as a Microbiology SME during site audits with clients, FDA, or other regulatory bodies. Works closely with Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, Finance, Business Development, and Project Management teams.
* Bachelor's degree in Biology and/or other related discipline (e.g. Biochemistry, Biotechnology).
* Minimum of 5 years pharmaceutical or testing experience.
* Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
* High level of experience in cGXP practices.
* Proficient computer skills in Microsoft Word, Excel, and Outlook.
* Equipment qualification/validation experience is preferred.
Responsibilities Include (but are not limited to):
* Provide leadership and guidance to the microbiology technical team. Assist in hiring, managing, motivating, coaching, and mentoring microbiologists.
* Review and approve microbiology documentation and procedures including material specifications, test methods, validation protocols, reports, standard operating procedures, and client work orders.
* Provide oversight in test method feasibility, development, and validation campaigns for client projects.
* Recommend and provide oversight for continuous laboratory improvements.
* Provide expertise in ICH and USP microbiology requirements and techniques. Provide support to QC team with lab investigations and troubleshooting as needed.
* Lead team meetings and discussions to achieve goals and deliver on departmental initiatives as needed.
* Work with EHS, safety officers, and other teams as necessary to implement safety best practices to ensure that the laboratory is a safe work environment. Recognize potential safety issues, discusses with EHS and management, and takes action to rectify them.
Full job description available during formal interview process.
What Sets GRAM Apart from Other Employers:
MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
PTO: Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
WELLNESS TIME OFF: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.
PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
PAY: Depends on Experience and is discussed during the interview process. Shift differential available for second and third shift!If you meet the required criteria listed above, GRAM welcomes you to apply today!
GRAM supports Equal Opportunity Employment