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:

Provide direction and leadership to Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Finishing Operations (Inspection, Labeling, Packaging). This position works closely with all levels of the Operations, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

Non-Negotiable Requirements:

* Bachelor's degree in Life Sciences or related field; In lieu of a bachelor's degree,

4+ years equivalent GMP/related work experience may be considered.

* 3 years prior experience in a QA Specialist role; prior leadership experience preferred.

* A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required

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

Preferred Requirements:

* Experience and expertise in aseptic manufacturing of regulated products.

* Prior experience interacting with regulatory authorities is preferred.

Responsibilities Include (but are not limited to):

* Provide supervision to Quality Specialists and Quality Technicians of various levels. Responsibilities include managing, motivating, coaching and mentoring.

* Ensure Quality support and oversight of Finishing operations across all shifts, including occasional weekend support.

* Oversight and management of the batch record review and final release processes.

* Client support / interaction related to these processes.

* Interface with auditors, including client representatives and regulatory agencies.

* Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including:

o Procedures

o Test Methods

o Master Batch Records

o Risk Assessment Reports

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.