Quality Lead - 2nd Shift

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.