Quality Assurance Specialist

Probi•Lafayette, CO

12h•Onsite

About The Position

The Quality Assurance Specialist supports the Quality Assurance unit in Colorado and reports to the Quality Manager. Under the guidance of the Quality Manager, the Quality Assurance Specialist is responsible for day to day quality operations related to the production, testing, and release of purchased and manufactured goods. They utilize quality skills to help identify and lead continuous improvement initiatives, ensure quality systems are being managed and executed timely, and are responsible for routine day-to-day functions. They are responsible for the CAPA and deviation management program, conducting change control activities, audit findings, document management, and investigations. This role forms partnerships with plant leadership to drive the success of the organization.

Requirements

Degree (BSc or MSc) or 4 years + equivalent experience in manufacturing quality role.
Minimum of 1 years working within a cGMP regulated environment for ingredients, food, and dietary supplements.
Ability to influence and collaborate effectively with stakeholders at any level of the organization.
Analytical mind, good attention to details and problem-solving skills within a structured process.
Demonstrated application of continuous improvement, change control and risk assessment.
Fluent in English – spoken and written.
Must be legally authorized to work in the US.
High school diploma or GED
Must be able to work safely and ensure the safety of others and be comfortable around heavy equipment and be able to lift 40 lbs.
Able to adhere to strict confidentiality policies and procedures.
Must be able to recognize audible and visual hazards.
Ability to read, write, and converse in the English language.
Must follow GMP, PPE, and company safety policies in the performance of job duties.
Must maintain good attendance.
Able to pass a background check.

Responsibilities

Support facility certifications (e.g., GRMA, NSF, Kosher, Halal) by maintaining compliant SOPs and records and promoting an “audit-ready” culture.
Maintain controlled documents by creating, revising, and issuing SOPs, forms, records, and policies; draft new documents as needed.
Manage and complete assigned tasks in the eQMS (e.g., customer cases/requests, audits, CAPA) to ensure timely closure and appropriate root-cause analysis, corrective actions, and effectiveness checks.
Support deviation management program by ensuring deviations are documented, risk-assessed, and addressed with appropriate actions.
Execute change control activities as assigned.
Manage calibration and verification programs ensuring testing equipment is properly maintained. (e.g., ATP testers, temperature monitoring devices).
Responsible for creating, reviewing, and approving Master Manufacturing Records (MMRs) and batch records.
Responsible for reviewing batch records and generating COAs.
Coordinate and manage label review, approval, control, and reconciliation programs.
Execute assigned customer cases and properly record actions and close records in eQMS system.
Execute assigned findings from audits and inspections. Document results, follow-up actions, and closure.
Maintain accurate, complete, and readily retrievable quality records in accordance with regulatory and company requirements.
Assist with customer complaints and support investigations using systematic methods to determine root cause and define corrective and preventive actions.
Act as designated back up for QA Technician/
Collaborate and influence stakeholders across Quality, Supply Chain, Product Development & Application, Suppliers, and Customers to resolve findings with fit-for-purpose, sustainable compliance solutions.
All other duties as assigned.

Benefits

Medical, vision, and dental coverage after 30 days (and first day of the following month). Three (3) plans to choose from.
Long-term and short-term disability insurance at no cost to employee.
PTO (Paid Time Off) accrues on hire with up to 4 weeks (20 days) for new hire and increases the longer you are with the company.
Participation in the company 401(K) and Roth plan after 6 months of employment with up to 4% employer match.
Ten (10) paid holidays.
Employee Assistance Program
17 hours per calendar year, to go out and volunteer in your community!
Yearly Safety shoe vouchers.
Learning and Development Opportunities
Monthly birthday and anniversary celebrations.
Team-building events throughout the year including summer and winter celebrations.