QC Senior Specialist

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteerism starting day 1

Paid time off up to 104 hours per year

Wellness time off

Job summary

Grand River Aseptic Manufacturing, Inc. is seeking a QC Senior Specialist to support quality systems in the analytical lab. You will own CAPA, INTCAPA, AI, NCR, TCR, OOS processes, manage training, and serve as QC SME for LIMS and equipment systems.

You will work with QC leadership, QA, validation, and IT to ensure timely, compliant deliverables and continuous improvement within a regulated facility in Michigan.

Qualifications

• Bachelor’s degree in Chemistry and/or related discipline with minimum 10 years regulated lab experience.

Responsibilities

• Process ownership for laboratory CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS with deliverables.
• Facilitate laboratory training program administration of approved trainers and scheduling.
• Serve as QC SME for LIMS including master data management, change assessment, and project support.
• Author/Review/Approve lab quality system deliverables and secure timely approvals.
• Act as QC lead on laboratory project teams and make independent decisions on deliverables.
• Serve as technical SME for topics like software method design, instrument troubleshooting, and personnel mentorship.
• Resolve technical issues with end users and vendors; build vendor relationships.
• Ownership of lifecycle management for laboratory equipment and systems.

Skills

Excellent written and verbal skills

Microsoft Word

Microsoft Excel

Microsoft Outlook

Education

Bachelor’s degree in Chemistry or related discipline

Master’s degree in Chemistry or related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Description

QC Senior Specialist

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?

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.

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!

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.