Quality Lead - 2nd Shift

Makers Pride•Kentwood, MI

16h•Onsite

About The Position

The Quality Lead is responsible for serving as a point of contact for QA Technicians on the shift when other supervision is not available. This role involves managing assigned FSQA programs, serving as backup for document specialist reviewer tasks and customer complaint investigations. The Quality Lead will maintain data entry into associated computer systems and collaborate with the QA team and other department personnel to meet requirements. This position is the primary owner of the Plant’s Hold Program and is responsible for verifying the quality of IRs and QNs, leading their closure by addressing issues directly or assigning them as appropriate.

Requirements

Solid understanding of quality systems, including product holds, investigations, complaint handling, and documentation.
Strong computer literacy.
Strong communication skills.
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.
High school diploma or GED equivalent (QAD approval otherwise) or Three – Five years of QA experience in FDA/USDA facilities.
At least one year of experience in a manufacturing or pharmaceutical environment.
Experience with Good Manufacturing Practices (GMPs).
Experience with Hazard Analysis Critical Control Points (HACCP).
Experience with FSMA (PCQI).
Experience with SQF.

Nice To Haves

Associates Degree in science field preferred, but not required.

Responsibilities

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.
Work with the QA team and other department personnel to meet requirements, assignments, trials, and responsibilities.
Serve as the primary owner of the Plant’s Hold Program.
Responsible for verifying the quality of IRs and QNs, leading their closure by addressing issues directly or assigning them as appropriate.
Maintaining and verifying the hold log, leading and presenting at hold meetings, and ensuring proper documentation and follow-through.
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.