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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:
Support quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include but are not limited to: provide oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supporting the Quality Management System.
Non-Negotiable Requirements:
- Bachelor's degree in Life Sciences or related field; In lieu of a bachelor's degree, equivalent GMP/related work experience may be considered.
- 2-5 years related work experience, including authoring and revising investigative documents and other quality related documents.
- Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
Responsibilities Include (but are not limited to):
- Author, revise, and review NCR, LIR, EIR, and PDR investigations.
- Exhibit complex conflict resolution and problem-solving skills in cross functional, collaborative setting.
- Initiate daily, weekly, and monthly quality metrics and trend reviews.
- Author and revise procedures in a timely manner to support CAPA and corrective actions.
- Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance. Triage and impact assessment for deviations associated with the aseptic filling process.
- Establish and maintain good technique with regards to working in classified areas (including gowning qualification).
- Review and approve executed batch records and other associated controlled documents.
- Perform QA review in-process and environmental monitoring test results.
- Perform QA review and material release for incoming materials.
- Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.
- Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, Logbooks, etc.
- Identify and participate as a team member in continuous improvement efforts.
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!
