Quality Lead - 2nd Shift

Maker's Pride; Grand Rapids (MI); On-site; USD 58,000 - 78,000; Full time

Benefits offered by this job

Health insurance and dental

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 in Grand Rapids, MI. You will act as the shift QA contact when supervision isn’t available, manage FSQA programs, and back-up document review and investigations.

You will verify IRs and QNs, lead hold procedures, assist with internal audits, and support GMP compliance while coordinating with the QA team and other departments.

Qualifications

• Solid understanding of quality systems including holds, investigations, complaint handling and documentation.
• Strong computer literacy and professional writing/communication skills.
• Proven ability to communicate clearly in virtual meetings (Teams) and email.
• GFSI/FSMA knowledge and audit readiness experience.

Responsibilities

• Maintain and verify the hold log, lead hold meetings and ensure documentation; manage close of hold items.
• Verify quality of IRs and QNs and drive issue closure.
• Provide backup for audits and be program owner for QA initiatives.
• Monitor QA Technicians during in-process QA checks and assist as needed.
• Perform GMP audits and oversee RCA-CAPAs; participate in mock traces/recalls as required.
• Support consumer/customer complaint investigations and product qualifications trials.

Skills

Quality systems understanding

Strong communication

Virtual presentation

Email responsiveness

Education

Associates Degree in science

High school diploma or GED

Tools

MS Office Suite

SAP

Job description

2nd Shift Position Hours: 3:30PM - 12:00AM (Schedule can be flexible) Weekend work may be required

What We Offer:

• 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.