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Quality Associate

3 hours ago

Wallingford, Connecticut, United States Blueroot Health INC. Full time

The Part-Time Quality Associate supports the Quality Department at the Wallingford Distribution Center. This role receives and manages components and retain samples, conducts sampling and inspections, and executes release decisions for third-party co-manufactured finished goods, packaging components, and received retains. The position maintains retain sample storage and logs, pulls retains for complaint investigations, reviews manufacturing jobs performed at Wallingford, and manages local document control. The associate also coordinates closely with the Middletown manufacturing facility (Production, Shipping/Receiving, and Quality) and maintains compliance with cGMP/GDP requirements under 21 CFR Part 111.

MAJOR RESPONSIBILITIES:

· Compliance with Standard Operating Procedures, GMPs and related systems that ensure company compliance and applicable regulations

· Receive, log, and stage incoming components and retain samples in accordance with SOPs.

· Maintain retain sample storage conditions, inventory, and chain-of-custody; pull retains to support complaint investigations.

· Perform sampling and visual/physical inspections of incoming materials and finished goods per approved methods.

· Review documentation (e.g., COAs, specifications, receiving records) and determine release/hold status for third-party co-manufactured finished goods, packaging components, and received retains.

· Perform quality approval and documentation review for manufacturing jobs executed at the Wallingford Distribution Center (e.g., kitting, rework, relabeling).

· Verify completion, legibility, and GDP compliance of all associated records; ensure line clearance and reconciliation requirements are met.

· Review and maintain quality documentation and logbooks for the Wallingford team.

· Execute local document control activities (issuing/archiving controlled documents and forms, processing requests from Middletown, ensuring current versions are in use).

· Coordinate with Middletown Production, Shipping/Receiving, and the main Quality team on releases, holds, investigations, and material movements.

· Escalate deviations, complaints, and potential quality issues promptly per SOP.

· Adhere to cGMP and GDP practices and maintain required training to ensure compliance with 21 CFR Part 111.

· Support internal/external audits and maintain inspection-ready work areas and records.

· Follow site safety, housekeeping (5S), and PPE requirements.

· Destruction of rejected/expired materials following company SOP's and guidelines

· Operate forklift and other power equipment as needed

· Must prepare and complete required documentation

· Perform additional duties as assigned

KNOWLEDGE/SKILLS/EXPERIENCE:

· Must have a high school diploma or general education degree (GED); Associates degree strongly preferred in Food Science, Nutrition, Biology, or Chemistry

· Experience in 

· Ability to read, write, and communicate about work instructions and safety information written in English

· Understanding of basic mathematical concepts

· Ability to analyze and interpret technical information

· Computer skills including MS office and material control programs

· Advanced organizational skills

· Ability to follow and interpret instructions whether written or spoken

· Ability to work well in a team

· Strong communication and interpersonal skills

· Punctual and reliable in work attendance

PHYSICAL REQUIREMENTS:

· Must be able to lift up to 50 pounds on a regular basis

· Operation of forklift and other power equipment

· Works near moving mechanical parts

· Vision requirements: Requires distance vision, color visions, peripheral vision, depth perception and ability to focus

· Must wear PPE and GMP appropriate for the position: non-slip footwear (boots), hair net, beard net (if applicable), face masks, nitrile food-grade gloves

Blueroot Health is an Equal Opportunity Employer. Employment opportunities at Blueroot Health are based upon one's qualifications and capabilities to perform the essential functions of a particular job. All employment opportunities are provided without regard to race, religion, sex, national origin, age veteran status, disability, genetic information, or any other characteristic protected by law. 

This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.  

Requirements