Quality Assurance Technician

Probi•Lafayette, CO

1d•Onsite

About The Position

The Quality Assurance Technician acts as the Quality Representative on the production floor and conducts quality activities in support of the programs and policies as required by 21 CFR 111, CFR 117, CFR 507, ISO 17025, ISO 22,000, other country / State requirements and specific customer expectations, as applicable. This position operates in close collaboration with production, warehousing, inventory, supply chain, and quality control.

Requirements

Experience working in an FDA regulated manufacturing facility.
Be able to work independently and in cross functional teams demonstrating ability to deliver results.
Experience with fermentation, food production, and/or dietary supplement manufacturing.
Possess advanced computer skills including Microsoft office suite as well as the ability to quickly adapt to new ERP and QMS systems.
Demonstrated skills in organizing work, taking initiative, setting priorities and sound decision making.
Possess logic, problem solving, and trouble shooting skills.
Must have strong critical thinking ability.
Strong Interpersonal, communication, coaching and conflict management skills.
Excellent oral and written communication skills to work effectively in a team environment.
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

Ensure work areas in the production and warehouse floor follow plant GMP requirements and meet all local, state and federal regulations.
Conducts raw material, works in process, and finished good sampling and conducts incoming receipt inspections.
Restock and maintain sampling supplies
Conduct tests of raw and finished products to ensure that products and documentation comply with standards, regulations and customer specifications.
Submit samples to appropriate labs for analysis.
Work with qualified third-party labs by coordinating sample submission and communicating on status to maintain expected lead times
Perform physical analyses and other specified lab tests utilizing defined methods and specifications.
Perform line clearance activities for manufacturing operations.
Perform label control and reconciliations activities
Maintain retain sample inventory.
Receive incoming samples from other departments.
Prepare samples for analysis as necessary.
Create accurate records, all conducted according to established policies and procedures.
Assist with raw material specification evaluation, releases, holds, and other disposition decisions.
Ensure appropriate segregation and labeling of products based on quality status
Conduct maintenance and cleaning of sampling booth and related quarantine warehouses.
Provide on the floor support to help with the investigation and troubleshooting of any food safety, quality, or process control related issues.
Assists QA management in the collection of data for the purpose of improving products and systems as necessary.
Perform verification system checks to ensure sanitation and quality systems are on track.
Performs internal plant GMP audit and corrects findings on the floor
Assists in the determination of root cause when there are quality deviations and reports on holds
Performs line inspections for startup and throughout the shift as necessary
Responsible for quality systems monitoring (ie, glass, brittle plastic, metal detector, ATP, adequate lighting)
Reviews in-process paperwork ensuring compliance to GDP requirements and other internal policies and procedures
Perform Product documentation control, scanning and filing
Performs other related duties as assigned by management.
Takes initiative and suggest improvements

Benefits

Medical, vision, and dental coverage after 30 days (and first day of the following month) with approximately 85% being paid by employer. 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.
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.