Quality Lead - 2nd Shift

Maker's Pride Talent Acquisition Team•Kentwood, MI

1d•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, 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.
Knowledge of GFSI and FSMA requirements.
Knowledge of Environmental Monitoring Programs.
Knowledge of QA Technician role and responsibilities.
Knowledge of Customer specs and expectations.
Proficiency in MS Office Suite and SAP.
Minimum of one year of experience in a manufacturing or pharmaceutical environment.
High school diploma or GED equivalent (QAD approval otherwise) or Three – Five years of QA experience in FDA/USDA facilities.

Nice To Haves

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.

Responsibilities

Maintaining and verifying the hold log, leading and presenting at hold meetings, and ensuring proper documentation and follow-through.
Verifying the quality of IRs and QNs, leading their closure by addressing issues directly or assigning them as appropriate.
Assisting with audit readiness, serving as a program owner, and providing back-up coverage across other QA roles when needed.
Monitoring and assisting QA Technicians performing in-process QA checks.
Participating in the Internal Audit program.
Performing GMP Audits.
Overseeing Incident Report generation and communication.
Leading and assisting in managing RCA-CAPAs.
Participating in Mock Traces / Recalls as necessary.
Performing and/or overseeing the PEM and Non-PEM swabbing programs.
Assisting in consumer/customer complaint investigations.
Serving as main QA contact for trials or new product qualification activities as assigned.
Tracking and ordering lab supplies.
Monitoring rework processes when conducted for compliance to standards.
Filing paperwork related to the GFSI system.
Maintaining hold inventory records.
Participating in sensory and other product reviews as required.
Providing necessary data for KPIs.
Performing QA Technician duties when required as back up.
Following Good Manufacturing Practices (GMPs) at all times.
Complying with all safety, health and environmental regulations as prescribed by law.
Complying with all Company rules, regulations and policies.
Performing other duties as assigned by QA leadership.