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:

Support the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provide quality oversight for incoming materials, internal and external projects, on-boarding of new clients and continued support of current clients. Review documentation and quality records. Support on capital expenditures (CAPEX), continuous improvement initiatives, and routine manufacturing operations as required. This position works closely with several departments at GRAM, including but not limited to: Incoming QA, Project Management, Filling and Finishing Operations, Quality Assurance Operations, Analytical Technical Services, Quality Control Analytical and Microbiology, Manufacturing Science and Technology, and Validation.

Non-Negotiable Requirements:

• Completion of a bachelor's degree in Life Sciences or a related field and/or a minimum of 1-3 years of related work experience for a Specialist I, 3-5 years for a Specialist II, 5-7 for a Specialist III, and 7+ years for a Sr. Specialist.
• Knowledge of QA principles and procedures in pharma, biopharma, and/or biotech manufacturing environment or manufacturing environment of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• QA Experience and expertise in aseptic environment.

Responsibilities Include (but are not limited to):

• Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of GRAM and client-driven projects including: Standard Operating Procedures; Test Methods; Raw Material, Component, and Finished Product Specifications; Risk Assessments including change control assessments; Master Batch Records; Validation Documents
• Support current clients and on-boarding of new client projects.
• Act as QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards as well as internal deadlines.
• Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices.
• Participate in deviation investigation teams to support quality investigations (NCR, LIR, SQIR, etc.).

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!