Description
QC Senior SpecialistAgility, 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 QC Senior Specialist supports quality systems as they relate to operations in the quality control analytical lab. Support and ownership of laboratory quality management systems (CAPA, INTCAPA, AI, NCR, TCR, OOS), laboratory training program, equipment qualification/maintenance, LIMS management, and laboratory CAPEX program. This position works closely with QC Laboratory Leadership, Laboratory System Administrator, Analytical Technical Services, Quality Assurance, Validation, and Computer System Validation departments. Position may be specialized by laboratory manager based on need.
Non-Negotiable Requirements:
- Bachelor’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and a minimum of 10 years regulated lab experience.
- Master’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and a minimum of 6 years regulated lab experience.
- Proficient computer skills in Microsoft Word, Excel, and Outlook.
Preferred Requirements:
- Excellent written and verbal skills; Ability to communicate effectively with management and staff by exhibiting excellent interpersonal skills.
Responsibilities Include (but are not limited to):
- Process ownership for laboratory CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS. Includes establishment of deliverables and successful completion of deliverables on time.
- Facilitate laboratory training program including administration of approved trainers and scheduling.
- Serve as the Quality Control subject matter expert (SME) for LIMS, including master data management, change assessment, and project support.
- Author/Review/Approve laboratory quality system deliverables, working cross-functionally to secure approvals in a timely fashion in order to meet deadlines.
- Act as Quality Control lead on laboratory project teams with the ability to make independent decisions regarding internal project deliverables.
- Serve as technical SME for critical topics for the QC department, including but not limited to software method design, laboratory instrument troubleshooting, and mentorship/training of laboratory personnel.
- Resolve technical issues and problems with end users and vendors.
- Develop a strong professional relationship with vendors, co-workers, and clients.
- Process ownership for lifecycle management of laboratory equipment and systems.
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!
PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness 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 Chemistry or a related discipline such as Biochemistry or Biotechnology, plus at least 10 years of regulated laboratory experience
- Master's degree in Chemistry or a related discipline such as Biochemistry or Biotechnology, plus at least 6 years of regulated laboratory experience
- Proficiency with Microsoft Word, Excel, and Outlook
- Excellent written and verbal communication skills and effective interpersonal skills
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.
