Quality Specialist

Primary Responsibilities:

• Position: Quality Specialist
• Location: Hybrid / onsite in Grand Rapids, MI - some travel to Bloomington, Indiana will be required to support the assignment.
• Shift: 1st shift primarily -- As most quality/manufacturing roles onsite, we need individuals to be somewhat flexible if issues occur that would cause someone to stay later. They have a great team culture, and they are looking to continue to foster that type of environment. So, they are only looking for individuals who have a passion for this space, allow flexibility, and are willing to roll up their sleeves/wear multiple hats within their team.
• $46-$50/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Requirements -

-Bachelor degree in Scientific field

-Minimum 5+ years of experience working with GMP pharmaceutical manufacturing

-Experience with aseptic manufacturing experience – either hands on or oversight of contamination control

-Previous experience with risk identification

-Expertise handing review and approval of batch record review, RFFP activities, CAPAs, change controls deviations, quality product complaints, and risk assessments

-Small molecule / STERILE (Sterility assurance) and aseptic behavior experience

-Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

-Excellent computer proficiency e.g MS Office, TrackWise, Minitab

-Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

-Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

-Previous experience with CMO/CDMO relationships

Job Description: We are seeking a highly motivated and detail-oriented Quality Person In Plant to support QA on the floor oversight at a Contract Manufacturing Organization (CMO). This individual will serve as the sponsor’s Quality representative, supporting risk identification. ensuring compliance with cGMP standards.

Primary Responsibilities:

-Act as the sponsor’s primary Quality point of contact at the CMO for manufacturing and quality-related decisions.

-Perform detailed review of batch records, manufacturing documentation, and associated quality records to support timely batch release.

-Collaborate with CMO teams to resolve manufacturing issues, deviations, and discrepancies in real time.

-Review investigations, change controls, and complaints related to manufacturing activities.

-Drive compliance initiatives to reduce non-conformances and improve documentation practices.

-Ensure adherence to cGMP regulations, internal quality standards, and applicable safety policies.

-Participate in audits, inspections, and readiness activities as needed.

-Support continuous improvement initiatives and quality system enhancements.