Description
Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? 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:
Provides quality support to both internal and external projects, including the on-boarding of new clients / client projects, capital expenditures (CAPEX), continuous improvement initiatives, and as required in routine manufacturing and finishing operations. This position works closely with Project Managers, Filling and Finishing Operations, Quality Assurance Operations, Analytical Technical Services, Manufacturing Science & Technology, Validation, and QC Analytical and Microbiology departments. This is not a remote role.
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.
- Experience and expertise 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
- Provide review of executed batch records in relation to initial technical transfer and process performance qualifications.
- Support current clients and on-boarding of new client projects.
- Manage Quality deliverables according to project schedules and ensure tasks assigned are delivered according to project timeline.
- Ensure that project deliverables meet all regulatory and industry best practice standards.
- QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards as well as internal deadlines.
- 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:
BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion 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 13 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: Employees earn 1 hour of time off for every 30 hours worked to use how 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.
If you meet the required criteria listed above, GRAM welcomes you to apply today!Skills Required
- Completion of a bachelor's degree in Life Sciences or a related field
- Minimum of 1-3 years of related work experience for a Specialist I
- Experience with QA principles in pharma, biopharma, or biotech manufacturing
- Understanding of cGMP, FDA guidelines, and multinational regulatory standards
- Proficient computer skills in Microsoft Word, Excel, and Outlook
What We Do
Grand River Aseptic Manufacturing (GRAM) is a leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for biologics, small molecules, and vaccines, offering capabilities for liquid and lyophilized vials, syringes, and cartridges.
