Quality Systems Specialist (Friday-Sunday 6:00am-6:30pm)

Main Duties & Responsibilities

• Ensure compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117, and Global Food Safety Initiative (GFSI) scheme;
• Review and approve folders to completion which entails verification of counts, printing and applying of excess labels, accurate bin moving and verification of correct counts of all finished product retains etc.;
• Affirm that every aspect of batch records is reconciled (Theoretical yield, final product yield, label reconciliation, waste, etc.) and documented completely;
• Good Documentation practices and record keeping;
• Complete QC Daily reports;
• Oversee and maintain internal audit program;
• Oversee and maintain non-conformance program;
• Responsible for external communications regarding complaint handling;
• Oversee and maintain traceability system;
• Provides document control support, as needed;
• Provides regulatory support, as needed;
• Monitor allergen handling throughout production by verifying cleans and labeling;
• Meet goals and objectives as outlined by the Executive Management team;
• Follow and enforce cGMP guidelines and processes as established in department SOPs;
• Perform other duties as deemed necessary.

Requirements And Skills

• High School Diploma required; some college experience preferred;
• 1-2 years’ experience in a similar setting;
• Detail oriented and highly organized;
• Working knowledge of Microsoft office and general computer concepts;
• Intermediate math, communication, and problem solving skills;
• Strong documentation practices and record keeping skills;
• Excellent written and oral communication skills;
• Ability to type 35 wpm;
• Ability to follow company processes and procedures;
• Ability to work without direct supervision;
• Ability to lift up to 15 lbs.;
• Ability to sit and stand for extended periods of time;
• Ability to work around a variety of different smells and aromas;
• Ability to view a computer screen and type for extended hours;
• Work environment is normally in an office setting.

Benefits

• Medical, Dental, Vision
• Employer paid STD and LTD
• HSA and FSA
• Paid Maternity and Paternity Leave
• PTO
• Employer paid Basic Life Insurance
• 401(k) & Roth with employer match
• Eight Paid Holidays + 3 Floating Holidays
• Voluntary - Critical Illness, Hospital Indemnity, Accident
• Personal growth including training and development opportunities