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 QA Systems Specialist - Change Control is responsible for direct and routine support of GRAM's Change Control Process. Utilizing the process and supporting documentation, control changes within GRAM's Pharmaceutical Quality System (PQS) to avoid unintended consequences to the safety, integrity, strength purity, and quality (SISPQ) of drug products manufactured. 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.
Bachelor's degree in Life Sciences or a related field and/or a minimum of 3-5 years related work experience.
Experience and expertise in pharmaceutical manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
Ability to interpret and relate Quality standards for implementation and review.
Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
Excellent written and verbal skills.
Proficient computer skills in Microsoft Word, Excel, and Outlook.
Experience with aseptic products desired.
Responsibilities Include (but are not limited to):
Process owner responsible for execution and administration of the change control process.
Lead cross-functional SMEs through the change control process from initiation through completion.
Interact with client quality partners on change execution and implementation strategies.
Schedule and participate in the site change control review board meetings.
Prepare and analyze change control metrics reporting for quality management review.
Ensure that project deliverables meet all regulatory and industry best practice standards.
Project a positive and professional image of GRAM and self by providing quality services to all internal and external customers.
Understand and is aware of the quality consequences which may occur from the improper performance of assigned job.
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!
PAID HOLIDAYS: We offer 8 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!
GRAM supports Equal Opportunity Employment