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 responsibilities of the Manufacturing Supervisor include, but are not limited to, the ability to Manage routine manufacturing tasks adhering to the guidelines of established procedures and cGMP regulations under direction of management. The Manufacturing Supervisor is also responsible for providing leadership and oversight during component and equipment preparation, bulk drug formulation and aseptic filling duties. This position supervises manufacturing activities over the weekend 12-hour, day shifts of Friday, Saturday, and Sunday.

Non-Negotiable Requirements:

* Bachelor's degree in life science or equivalent training and/or experience is necessary.

* Minimum 3 to 5 years of relevant pharmaceutical experience required.

* Experience in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and regulatory/compliance standards.

* Proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

* Experience in a CMO and sterile filling facility preferred.

* Proven leadership experience and self-starter.

Responsibilities Include (but are not limited to):

* Accurately document data, complete batch records and execute documentation review as needed.

* Continually audit all personnel for compliance and use of proper aseptic technique.

* Support and enforce the departmental vision, goals and quality standards.

* Oversee operations in cleanroom environment.

* Communicate cross-functionally to provide schedule updates and information about any quality events.

* Participate in client communications, including problem solving, schedule development, and project status updates.

* Complete proper, real-time investigations and collects data for deviation/root cause analysis.

* Perform routine performance assessments with direct reports.

* Define and uphold disciplinary actions for poor performance of direct reports, as necessary.

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!