Sisel International

Manufactures personal care products and supplements

Document Control Specialist

Regulatory & Quality (Life Sciences)Posted on Nov 11

Full-timeSpringville, UT, USANo salary listedIn-person

About the Job

Requirements

A high school diploma or equivalent is required.
One to two years of work experience in production or quality in a nutraceutical or pharmaceutical environment is preferred.
Proficiency in Microsoft Office applications is required.
Familiarity with federal and state regulations concerning dietary supplement requirements is required.
Ability to read, speak, and understand English is required.
Ability to perform repetitive tasks such as updating forms, filling logs, copying, and scanning documents is required.
Ability to work effectively with others when editing or revising documents is required.
Ability to organize work, attend to detail, work under pressure, and plan workload effectively is required.
Ability to delegate is required.
Ability to sit, stand, walk, stoop, bend, reach, kneel, and occasionally lift at least 30 pounds is required.

Responsibilities

Review and approve standard operating procedures, policies, and current good manufacturing practice documents.
Ensure projects, initiatives, and processes conform to established company policies and procedures.
Review master manufacturing records, batch records, test records, and supplier specifications to ensure compliance with federal or state regulations.
Review and approve packaging records and finished product release documentation.
Maintain specification control, filings, and change history.
Distribute quality-system documents for review and authorization as required.
Control and distribute documents and specifications to appropriate internal contacts, suppliers, and contract manufacturers.
Maintain the system requirements, formats, and procedures used to produce, approve, release, control, and archive controlled documents.
Conduct periodic audits of standard operating procedures and records, and report results to ensure alignment with updated processes and regulatory changes.
Oversee and maintain the retain sample program in accordance with FDA current good manufacturing practice and company requirements.
Train and assist personnel in using specifications and standard operating procedures.
Update the training database with employee training based on records submitted to document control, maintain training files, and send companywide training notifications.
Participate in regulatory and third-party audits.
Cross-train in other quality-related functions.
Perform other assigned duties and responsibilities.

Desired Qualifications

Oracle experience is a plus but is not required.

POSITION PURPOSE AND SCOPE:
The Document Control Specialist is responsible for supporting and maintaining the company’s compliance with applicable quality standards. This includes oversight of cGMP practices, quality systems, documentation, product labeling. This role is critical in ensuring products are safe, effective, and compliant with all regulatory requirements.

ESSENTIAL RESPONSIBILITIES:

Review and approve all SOP’s, policies and cGMP documents.
ensures all projects, initiatives and processes are in conformance with company established policies and procedures.
Review all Master Manufacturing Records, Batch Records, Test Records, and Supplier Specifications to ensure they meet federal or state regulations.
Review and approve packaging records and finished product release documentation.
Maintain specifications control, filings, and change history.
Distribute quality system documents for review and authorization as required.
Control and distribute all documents and specifications to proper internal contacts, suppliers, and contract manufacturers.
Maintain the systems requirements, formats, and procedures to produce, approve, release, control and archive controlled Documents.
Conduct periodic audits of SOPs, record, and report results to ensure alignment with updated processes and regulatory changes.
Oversee and maintain the retain sample program in accordance with FDA CGMP and company requirements.
Train and assist personnel in the use of specifications and SOPs.
Update training database with employee training based on training records submitted to document control. Files and maintains the training files. Sends out companywide training notifications.
Participate in regulatory and third-party audits.
Cross train in other Quality related functions.
Any other duties and/or responsibilities as assigned.

EDUCATION EXPERIENCE:
High school diploma or equivalent plus 1-2 years’ work experience in production/quality with nutraceutical or pharmaceutical environment preferred.

SKILLS AND ABILITIES:

Must be able to work well with others especially when editing or revising their documents.
Must be willing to perform repetitious tasks such as updating forms, filling logs, copying, and scanning documents.
Proficiency in Microsoft Office applications is required. Oracle experience a plus, but not required.
Must be flexible and adaptable to a fast pace, changing environment.
Possess a positive attitude; be an excellent team player.
Familiar with Federal and State regulation concerning dietary supplement requirements.
Good Organization Skills and extremely detail oriented.
Ability to work under pressure, plan personal workload effectively and delegate.
The ability read, speak and understand English.

PHYSICAL DEMANDS:
Positions is required to sit, stand and walk, stoop, bend, reach and kneel. Lift at least 30lbs plus on occasion.

WORK ENVIRONMENT:
Noise, dust, lighting, temperature, and physical/ergonomic hazards are typically those usually found in an office environment.

About the Company

Sisel International

Manufactures personal care products and supplements

Sisel International develops and markets personal care products and dietary supplements. The company conducts scientific research to create formulas that emphasize potency, safety, and longevity, and it manufactures all products in-house under GMP standards to ensure high quality. Its lineup is designed with strong dosages and efficacious ingredients, across personal care items and dietary supplements. Sisel differentiates itself through its in-house production workflow, a science-focused approach, and a global presence in more than 40 countries, all while promoting a home-based business opportunity built on quality and integrity. The company’s goal is to offer safe, effective products and reliable income opportunities, with continued global expansion.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Springville, UT
Founded: 2006

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