Quality Assurance Technician

Somafina

Lindon (UT)

On-site

USD 28,000 - 39,000

Full time

3 days ago

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Job summary

somafina, a nutraceutical contract manufacturer in Utah, seeks a Quality Assurance Technician to join the Quality Department. The role reviews batch records to ensure production and packaging meet specifications and coordinates timely closure of records so finished goods can be released.

You will work with strategic customers on controlled documents, ensure compliance with cGMP and FDA regulations, and support audits in a fast-paced environment.

Qualifications

Three to five years of quality experience in the dietary supplement space.
Knowledge of cGMPs and FDA regulations in nutraceuticals.
Proficiency with MS Office; Excel required.
Strong attention to detail and communication.

Responsibilities

Reviews batch production records for conformance.
Close out batch records in a timely fashion and resolve roadblocks.
Reviews Certificates of Analysis (COAs).
Liaises with production and customer service to ensure compliance with regulations.

Skills

cGMPs

FDA regulations

SOP enforcement

Auditing

Attention to detail

Written communication

Verbal communication

Excel

Time management

English proficiency

Education

High school diploma or GED

Job description

somafina

Nutraceutical Manufacturing

Quality Assurance Technician

Quality Department

Full-Time
Hourly Non-Exempt

3–5 Years Quality Experience In Dietary Supplements

Why Somafina?

Somafina is an industry leader in contract manufacturing of dietary supplements. We pride ourselves on our superior commitment to maintaining the highest quality standards while fostering a company culture that is collaborative and supportive.

Position Description

The Quality Assurance Technician is a vital part of the Quality Department and the company. This position is responsible for reviewing batch production records to ensure products in both the production and packaging areas are produced within required specifications, and for ensuring that batch records are closed out in a timely fashion. The Quality Assurance Technician chases down and overcomes roadblocks in reviewing and closing batch records so the quality team can release finished products, and reports the status of finished product release to upper management.

The Quality Assurance Technician also works with strategic customers to provide the controlled documents they need to approve the release of finished products, and helps ensure that all company policies and procedures are followed. This position requires three to five years of quality experience in the dietary supplement space.

Essential Responsibilities

Batch Record & Document Review

Reviews batch production records to ensure products in both the production and packaging areas are produced within required specifications.
Ensures batch records are closed out in a timely fashion, chasing down and overcoming roadblocks so the quality team can release finished products.
Reviews Certificates of Analysis (COAs).
Performs point step process review and materials review.

Quality & Compliance

Ensures product specifications are met and company policies and procedures are followed and adhered to.
Ensures production of products meets the company’s stringent quality standards from start to finish.
Liaises with production and customer service departments to ensure projects are initiated, executed, and completed according to federal regulations, including cGMPs and FDA regulations for dietary supplements.

Reporting & Customer Support

Reports the status of finished product release to upper management, clearly presenting facts and figures.
Works with strategic customers to provide essential controlled documents needed for customers to approve the release of finished products.
Manages projects related to batch record closure and finished product release.

Additional Responsibilities

Adheres strictly to company policies and procedures.
Performs other duties as assigned by supervisor.

Education Requirements

High school diploma or general education degree (GED); or three to five years of experience in quality in the dietary supplement space.

Competencies / Skill Qualifications

Knowledge of dietary supplement cGMPs and FDA regulations, with experience in the dietary supplement / nutraceutical industry.
Experience enforcing SOPs and product specifications; auditing experience preferred but not required.
Extreme attention to detail.
Exceptional written and verbal communication skills.
Ability to follow instructions and directions, and to make decisions based on company guidelines.
Ability to work well under pressure in a fast-paced environment.
Exceptional organizational, multitasking, and time-management skills, with the ability to prioritize and complete assigned tasks effectively and efficiently.
Ability to adapt to a dynamic environment and maintain effectiveness during times of major changes in responsibilities.
Demonstrates integrity and willingness to take personal responsibility for performance.
Proficiency with all MS Office Suite programs; Excel experience required.
Strong mathematics skills required.
English proficiency required.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; converse and listen; and taste or smell.
Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
May be exposed to a dusty environment and/or considerable noise.

Character Requirements