Description

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 Micro Supervisor supports and manages quality systems as they relate to environmental control in an aseptic processing operation, and all other microbiology testing related to customer products and GRAM operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing. This position supports a 24/7 facility.

Non-Negotiable Requirements:

* Bachelor's degree in microbiology or a related field.

* 5 years' experience in a Microbiology laboratory supporting an aseptic, or related, manufacturing process.

* 1 year of prior leadership experience.

* Knowledge of QA/QC principles and procedures in a pharma, biopharma, and/or biotech

manufacturing environment.

* Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Responsibilities Include (but are not limited to):

* Manage day to day prioritization of routine, in-process, stability and finished product testing.

* Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities.

* Lead training of all new employees and maintain all training documentation via current system.

* Support the EIR system and assist in any related Laboratory Investigations, CAPA's, or NCR's.

* Oversight of all equipment use and equipment calibration logs.

* Establish and maintain good technique with regards to working in an aseptic environment.

* Independently author or revise internal test methods and standard operating procedures.

* Review EM trending data, quarterly, and annual summary reports.

* Review process and testing documentation as needed to ensure complete and accurate records are maintained.

* Assesses process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes.

* Participate in cross-functional meetings and training sessions with manufacturing operations.

* Coordinate with contract testing laboratories and experts as needed.

* Participate in vendor, client and regulatory audits as a microbiology subject matter expert, prepares documents for review and speaks to GRAM processes and procedures to answer auditor questions.

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.