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:
The QA Systems Specialist supports quality systems related to the manufacturing and testing of cGMP drug products including Non-Conformance (NCR), Corrective Action/Preventive Action (CAPA), Change Control (CC), and Effectiveness Verification (EV). These duties will include but will not be limited to, applying process level knowledge to oversight and daily management of the quality system processes, SOP creation and revision, actively facilitating and/or participating in cross functional teams to support investigation completion, implementation of quality system deliverables, and maintaining efficient processes as part of the overall Quality Management System.
Non-Negotiable Requirements:
- Bachelor’s degree in Life Sciences or related field, or minimum 4-8 years related work experience (or equivalent combination of education and experience.
- Knowledge of QA principles and procedures in a pharma, biopharma, medial device, or biotech manufacturing environment is required.
- Experience in pharmaceutical or medical device manufacturing or regulated products with an understanding of cGMP and FDA guidelines and standards is required.
Preferred Requirements:
- Experience in data analysis and reporting preferred
- Experience in aseptic manufacturing and an understanding of multinational regulatory standards is preferred
- ASQ and/or Green Belt Certification is preferred
- Experience in quality systems regulations CFR 820 and/or ISO 13485 is preferred
Responsibilities Include (but are not limited to):
- Oversight and daily management of the quality systems associated with all aspects of operations processing and batch release.
- Identify support and/or lead continuous improvement initiatives that will result in more effective, efficient and/or complaint quality system processes.
- Lead and/or facilitate cross-functions team discussions with the goal of achieving robust and detailed root cause investigations.
- Lead and/or facilitate completion of qualify systems deliverables.
- Administer and act as the process owner for one or more quality systems.
- Train and mentor personnel on Root Cause Analysis investigations tools.
- Prepare and provide training to users on quality system processes, procedures, and the best practices.
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 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
- Bachelor's degree in Life Sciences or related field, or equivalent combination of education and experience (minimum 4-8 years)
- Knowledge of QA principles and procedures in pharma, biopharma, medical device, or biotech manufacturing environments
- Experience in pharmaceutical or medical device manufacturing or regulated products with understanding of cGMP and FDA guidelines and standards
- Experience in data analysis and reporting
- Experience in aseptic manufacturing and understanding of multinational regulatory standards
- ASQ and/or Green Belt Certification
- Experience with quality systems regulations CFR 820 and/or ISO 13485
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.
