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    Quality Assurance Specialist - Anaheim, United States - Nutritional Supplement Manufacturer

    Nutritional Supplement Manufacturer
    Nutritional Supplement Manufacturer Anaheim, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    Summary: The Quality Assurance Specialist is responsible for the management and maintenance of the GMP documents, which include but are not limited to Production Batch Records, third-party COAs, Samples logs, SOP revisions, and other GMP-related documents. The Quality Assurance Specialist is also responsible for entering and generating operational-related documents.

    Duties and Responsibilities:

    · Review batch records for Production/Packaging for accuracy and completeness

    · Initiates change control for document changes.

    · Prepares metric reports for management.

    · Revise and update SOPs.

    · Captures customer complaints and responds to complaints.

    · Assists in the management of CAPA system.

    · Support QA Operation functions

    · Performs and documents a wide variety of inspections, checks, tests, and sampling. procedures from incoming receipt to packaging and distribution.

    · Assists and supports QA/QC Management in overseeing QA activities and training.

    · Monitors all aspects of production to ensure adherence to cGMP and SOPs.

    · Performs line clearance for removal of all previous products, components, and foreign materials.

    · Performs first article and in-process inspections.

    · Communicates non-conformances to Supervisor and recommends corrective actions.

    · Reviews documentation to ensure accuracy and completeness.

    · Performs reconciliation and closing of batch records.

    · Assists management in conducting inquiries and investigations.

    · Ensures timely release of finished goods.

    · Maintains quality records, reports, logs, and retention samples.

    · Coordinates destruction of expired records, documents, and products

    · Assists in the preparation of customer and regulatory audits.

    · Performs other related duties as assigned by management.

    Work Experience/Qualifications:

    · Minimum of 2 years relevant work experience in document control management.

    · Working knowledge of cGMPs and FDA regulations as it pertains to document control.

    · Good interpersonal skills.

    · Ability to work independently and in a team environment.

    · Ability to read, write, and speak English.

    · Ability to perform basic math.

    · Ability to follow instructions.

    · Good attendance and punctuality.

    · Flexibility to change priorities, work schedules, and business needs.

    · General proficiency in using Microsoft Word, Excel, and Outlook.

    · Ability to work well under pressure.

    · Highly organized and detail-oriented, able to work effectively in a fast-paced work environment.

    Education Requirements:

    · Minimum High School Diploma or equivalent.

    · ASQ CQA and/or CHA certification preferred.

    Work Environment:

    · The work environment characteristics described here represent those an employee encounters while performing this job's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    · While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock.

    · The noise level in the work environment is usually moderate.

    · While in the plant, the employee must utilize the required personal protective equipment.

    Physical Demands:

    · The physical demands described here represent those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    · Physical demands require sitting and walking for extended periods of time, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.



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