Quality Lead - 2nd Shift
2nd Shift Position
Weekend work may be required. Hours: 3:30 PM – 12:00 AM (Schedule can be flexible).
What We Offer
We offer a competitive wage and a 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, managing assigned FSQA programs, serving as backup for document specialist reviewer tasks, serving as a back‑up for customer complaint investigations when needed, maintaining data entry into associated computer systems as necessary, and working 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
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.
Assist 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 backup.
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
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).
Responsive to email communication and able to represent the QA function clearly and effectively.
Knowledge of GFSI and FSMA requirements.
Familiarity with environmental monitoring programs.
Knowledge of QA Technician role and responsibilities.
Understanding of customer specs and expectations.
Proficiency in
MS Office Suite and SAP.
Minimum Qualifications
High school diploma or GED equivalent (QAD approval otherwise) or 3–5 years of QA experience in FDA/USDA facilities.
At least one year of experience in a manufacturing or pharmaceutical environment.
Associate's degree in a science field preferred, but not required.
Experience with GMPs, HACCP, FSMA (PCQI), and SQF all pluses.
Maker's Pride is an Equal Opportunity Employer. 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.
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