QA/QC Specialist

Position Summary

The Quality Assurance/Quality Control Specialist is responsible for completing quality documentation and testing requirements for the release of product. This role ensures data information is consistent and accurate for raw materials, in-process, and finished products, verifying that products meet or exceed standards and customer requirements. The Specialist assists with document control, SOP revisions, monitoring quality systems, regulatory compliance, and internal/external auditing to support overall site quality and regulatory objectives.

Principal Duties & Responsibilities

1. Maintain compliance with Mandatory Standards and Requirements (MMSRs), FDA, OSHA, and EPA regulations.
2. Support full cGMP compliance with FSSC 22000, ISO 9001, 21 CFR 117, 21 CFR 507, Natural Soda Quality Policies, and Huber EH&S policies.
3. Maintain records of raw material and finished product documentation and testing results.
4. Direct product and raw material sampling and testing; ensure that all required quality tests are performed using standard lab procedures to support shipments and receipts within guidelines.
5. Serve as Quality Manager backup, including authority to make shipment or rejection decisions based on testing results.
6. Manage Document Control and maintenance of site-level procedures, forms, and batch records.
7. Acquire, record, distribute, and maintain accurate quality information and records per cGMP and Quality Policies. Create Master Batch Record templates and issue Batch Records with quality review approval.
8. Generate accurate and timely Certificates of Analysis and other requested documents for customers.
9. Participate in maintenance of HACCP plans and coordinate annual reviews.
10. Support Annual/Quarterly Product Quality Review testing and reporting on product trends, First Pass Yields, Cost of Poor Quality, and other performance metrics.
11. Coordinate Environmental, Pest, Glass & Brittle Plastic sampling, recordkeeping, and document maintenance.
12. Support internal and external audits and continuous improvement of existing quality systems, including hazard analysis and critical control points.
13. Maintain QC Lab instrument calibrations and ensure compliance with lab standards.
14. Complete inspections and shipment of sample requests.
15. Promote good housekeeping practices and ensure a clean work environment.
16. Follow all company policies, procedures, and regulatory requirements.
17. Perform other related duties as assigned.

Specialized/Technical Knowledge or Required Skills

1. BS degree in a technical field preferred.
2. Minimum of high school diploma/GED and applicable work experience.
3. Minimum five years total lab experience (higher education may substitute).
4. Strong written communication skills.
5. Ability to read and interpret scales, charts, drawings, formulas, and specifications.
6. Proficient in arithmetic calculations including decimals and fractions.
7. Advanced knowledge of pharmaceutical, food regulations, and/or plant operations.
8. Ability to prepare and maintain detailed reports and records.
9. Proficiency in Microsoft Office programs and laboratory software.
10. Strong analytical, organizational, and problem-solving skills.

Working Conditions

1. Work primarily in climate-controlled office and laboratory environments with occasional exposure to chemicals, dust, noise, and temperature variations.
2. Regular standing, walking, climbing stairs, and occasional lifting up to 50 lbs.
3. May work in confined spaces and at heights as needed.
4. Use of personal protective equipment (PPE) required in designated areas.
5. Frequent use of close/distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
6. Must be able to work assigned schedules, including weekends, evenings, and holidays, and be available for call-out during emergencies or critical events.

Total Rewards

J.M. Huber Corporation complies with all local/state regulations requiring salary range transparency.

Any offered salary is determined based on relevant factors such as an applicant's skills, performance, job responsibilities, prior relevant experience, certain degrees and certifications and market considerations.