Quality Lead - 2nd Shift

Maker's Pride; Grand Rapids (MI); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health/dental/vision insurance

Flex spending accounts

Short & long-term disability

Paid holidays and vacation

Bonus opportunities (referral, etc.)

Job summary

Maker's Pride is seeking a Quality Lead for the 2nd shift to act as QA point of contact when supervision isn’t available. You will manage QA programs, back up documentation review, and support customer complaint investigations while ensuring data accuracy across systems.

The role includes leading hold program ownership, verifying IRs/QNs, and coordinating with the QA team to meet regulatory and company standards. Weekend work may be required on occasion.

Qualifications

• Solid understanding of quality systems, holds holds, investigations, complaint handling and documentation.

Responsibilities

• Maintain and verify the hold log, lead hold meetings, ensure documentation and follow-through.
• Verify quality of IRs and QNs, close issues or assign as needed.
• Act as program owner for QA and provide backup across QA roles.
• Monitor QA Technicians performing in-process QA checks.
• Participate in Internal Audits and GMP Audits.
• Oversee incident reports and RCA-CAPAs.
• Support in mock traces/recalls and product qualification activities.
• Follow GMPs and safety regulations at all times.

Skills

Quality systems

Audits

Documentation

Team coordination

Education

High school diploma or GED

Associate degree in science (preferred)

Tools

MS Office Suite

SAP

Job description

2nd Shift Position

Weekend Work May Be Required

What We Offer:

We offer a competitive wage and wide array of benefits including:

• health/dental/vision insurance
• flex spending accounts
• short & long-term disability
• paid holidays and vacation

2nd Shift Position

Hours: 3:30PM - 12:00AM (Schedule can be flexible)

Weekend Work May Be Required

What We Offer:

We offer a competitive wage and wide array of benefits including:

• health/dental/vision insurance
• flex spending accounts
• short & long-term disability
• paid holidays and vacation
• bonuses opportunities (referral, production, etc.).

About The Quality Lead Role

Quality Lead is responsible for serving as a point of contact for QA Technicians on the shift when other supervision is not available, manage assigned FSQA programs, serve as backup for document specialist reviewer tasks, serve as a back-up for customer complaint investigations when needed, maintain data entry into associated computer systems as necessary, and work with the QA team and other department personnel to meet requirements, assignments, trials, and responsibilities. They will also serve as the primary owner of the Plant’s Hold Program and will also be responsible for verifying the quality of IRs and QNs, leading their closure by addressing issues directly or assigning them as appropriate.

Job Duties

Duties may include, but are not limited to the following:

• Maintaining and verifying the hold log, leading and presenting at hold meetings, and ensuring proper documentation and follow-through.
• Be responsible for verifying the quality of IRs and QNs, leading their closure by addressing issues directly or assigning them as appropriate
• Assists with audit readiness, serves as a program owner, and provides back-up coverage across other QA roles when needed
• Monitor and assist QA Technicians performing in-process QA checks
• Participate in the Internal Audit program
• Perform GMP Audits
• Oversee Incident Report generation and communication
• Lead and assist in managing RCA-CAPAs
• Participate in Mock Traces / Recalls as necessary
• Perform and/or oversee the PEM and Non-PEM swabbing programs
• Assist in consumer/customer complaint investigations
• Serve as main QA contact for trials or new product qualification activities as assigned
• Track and order lab supplies
• Monitor rework processes when conducted for compliance to standards
• File paperwork related to the GFSI system
• Maintain hold inventory records
• Participate in sensory and other product reviews as required
• Provide necessary data for KPIs
• Perform QA Technician duties when required as back up
• Follow Good Manufacturing Practices (GMPs) at all times
• Comply with all safety, health and environmental regulations as prescribed by law
• Comply with all Company rules, regulations and policies
• May be required to work weekends from time to time
• Perform other duties as assigned by QA leadership

Required Competencies & Knowledge

• Has a solid understanding of quality systems, including product holds, investigations, complaint handling, and documentation.
• Strong computer literacy, communication skills, and professionalism in writing and virtual presentation (e.g., Teams meetings).
• Must be responsive to email communication and able to represent the QA function clearly and effectively.
• GFSI and FSMA requirements
• Environmental Monitoring Programs
• QA Technician role and responsibilities
• Customer specs and expectations

Proficiency in: MS Office Suite and SAP

Minimum Qualifications

• High school diploma or GED equivalent (QAD approval otherwise) or Three – Five years of QA experience in FDA/USDA facilities
• Candidates must have at least one year of experience in a manufacturing or pharmaceutical environment to be considered
• Associates Degree in science field preferred, but not required
• Experience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP), FSMA (PCQI), and SQF all pluses

Sponsorship for work authorization is not available for this position. It is the candidate’s responsibility to ensure they are legally authorized to work in the location to which they apply.

Maker's Pride is an Equal Opportunity Employer.