Document Control Specialist

1 month ago

Vista, United States Captek International Full time

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world's most successful brands.

Summary: It is the responsibility of the Document Control Specialist to create, manage and maintain GMP documents, which include but are not limited to Standard Operating Procedures, Master Manufacturing Records, Production Batch Records, test data sheets, MSDS's, controlled forms, and other GMP related documents.

Essential Duties and Responsibilities:

  • Manage document processes and systems to ensure control and availability of documentation to site personnel.
  • Coordinate the creation, revision, and distribution of controlled documents to plant management.
  • Assign control number to Document Change Requests.
  • Format documents submitted to Document Control.
  • Review change request documents to assure accuracy and completeness.
  • Create Master Manufacturing Records and route for review and approval.
  • File and maintain documents.
  • Coordinate destruction of expired records and documents.
  • Issuance of batch records and verification of in-process parameters in RedZone.
  • Perform other related duties as assigned by QA Supervisor.
Qualifications:
  • Minimum of one-year relevant work experience in document control management and/or equivalent combination of education and experience.
  • Technical writing experience preferred.
  • Competencies:
    • Good verbal and written communications
    • Ability to follow instructions
    • Ability to work independently and in a team environment
    • Ability to edit and proof documents
    • Good attendance and punctuality
    • Excellent organizational skills/attention to detail/ability to work under pressure
    • Ability to prioritize work and multi-task
    • Strong interpersonal skills
Education/Experience:
  • Minimum High School Diploma, AA or higher degree preferred.
  • Working knowledge of cGMPs and FDA regulations as it pertains to document control

Work Environment:

Thework environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. 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.

Physical Demands:

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

The employee must occasionally lift and/or move 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 occasionally 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 and talk or hear.

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.

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