Description
The Quality Systems Specialist is responsible for overseeing the Quality Management System by ensuring quality products meet internal and customer specifications.
- 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 completed production work orders;
- Assure that every aspect of batch records is reconciled( 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;
- Perform other duties as deemed necessary.
Requirements
- 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. Must be able to make frequent rounds in a warehouse environment;
- Other physical requirements include moderate standing and occasional squatting, bending, and twisting;
- Ability to wear any required PPE;
- Ability to adjust work schedule as business needs require.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.