Quality Lead - 2nd Shift

2nd Shift PositionHours: 3:30PM - 12:00AM (Schedule can be flexible)Weekend work may be requiredWhat 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 appropriateAssists with audit readiness, serves as a program owner, and provides back-up coverage across other QA roles when neededMonitor and assist QA Technicians performing in-process QA checksParticipate in the Internal Audit programPerform GMP AuditsOversee Incident Report generation and communicationLead and assist in managing RCA-CAPAsParticipate in Mock Traces / Recalls as necessaryPerform and/or oversee the PEM and Non-PEM swabbing programsAssist in consumer/customer complaint investigationsServe as main QA contact for trials or new product qualification activities as assignedTrack and order lab suppliesMonitor rework processes when conducted for compliance to standardsFile paperwork related to the GFSI systemMaintain hold inventory recordsParticipate in sensory and other product reviews as requiredProvide necessary data for KPIsPerform QA Technician duties when required as back upFollow Good Manufacturing Practices (GMPs) at all timesComply with all safety, health and environmental regulations as prescribed by lawComply with all Company rules, regulations and policiesMay be required to work weekends from time to timePerform other duties as assigned by QA leadershipRequired 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 requirementsEnvironmental Monitoring ProgramsQA Technician role and responsibilitiesCustomer 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 facilitiesCandidates must have at least one year of experience in a manufacturing or pharmaceutical environment to be consideredAssociates Degree in science field preferred, but not requiredExperience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP), FSMA (PCQI), and SQF all plusesSponsorship 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.