Quality Systems Documentation Specialist

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Quality Systems Documentation Specialist

St. Louis, Missouri

|

Full Time Temporary/Contract

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NA

St. Louis, Missouri

Full Time Temporary/Contract

NA

June 11, 2024

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Job ID: LSNJN-CR2_1718119928

June 11, 2024

Job ID: LSNJN-CR2_1718119928

Job Summary

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Summary of Position

The Contract Quality Systems Documentation Specialist is responsible for assisting in the management and administration of the Document Control systems to ensure compliance to applicable internal procedures, cGMPs, and regulatory requirements. The position is responsible for document processing, maintenance of documents/ records, issuance of logbooks, notebooks and protocols, and maintenance of various indices/ logs.

Essential Functions

  • Process various site documents using computer-based systems, including, but not limited to, Standard Operation Procedures (SOPs), Standard Certification Methods (SCMs), Standard Testing Methods (STMs), Specifications, and Batch Production Records.
  • Catalog, scan, maintain, archive/file and retrieve various site documents/ records, including, but not limited to, SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents, and Validation Protocols.
  • Update various information indices (Excel, Access, etc.) as necessary.
  • Prepare logbooks and issue logbooks and notebooks for use across the site.
  • Support Regulatory Affairs (US and Canada) by assisting in gathering information for submissions and annual reports.
  • Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance with applicable SOPs and cGMPs.
  • Assist with audits (preparation, set-up, breakdown, retrieval of requested documents).
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
  • Ensure maintenance of the department, premises, and equipment.

Requirements

  • Associates degree preferred, High School Diploma or equivalent is required.
  • 1 or more years of documentation experience in a cGMP facility or in the medical transcription field is required. Office administration experience will also be considered.
  • Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point.
  • Willing to work occasional overtime and weekends as the business need dictates.
  • Ability to work well both independently and in a team atmosphere.
  • Demonstrated ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures required.
  • Ability to accurately type 45 words per minute.
  • Strong grammatical and document layout/design/formatting skills are mandatory.
  • Strong organization skills are essential.
  • Good communication skills.
  • Strong organization and time management skills.
LSNJN-CR2_1718119928

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™