Quality Assurance Document Control Specialist

Description

• Maintain a document library and spreadsheet, logging information as it is sent, received, and reviewed.
• Be aware of record retention timelines, alerting department superiors of upcoming document cleanups.
• Keep the central repository updated on the shared drive.
• Control documents for all Standard Operating Procedures and forms, logging updates for new and revised procedures.
• Gather and maintain files of necessary documents based on quality and regulatory requirements from vendors supplying raw materials and components.
• Update quality employees on requested and made changes to documents.
• Update supplier and vendor contact lists for reference when requesting product information.
• Create and provide documents requested by sales and customer service representatives, including written statements and supplier information.

Requirements

• Effective oral and written communication skills.
• High school diploma or equivalent required; Associates or Bachelors degree considered beneficial.
• Strong leadership skills.
• Highly organized with effective prioritization abilities.
• Competence with computer software including word processors and spreadsheets (Microsoft Word, Excel, Access).
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, and SDS sheets.
• Proficiency in basic arithmetic operations.
• Adherence to health and safety regulations, including constant use of protective gear.
• Familiarity with cGMP standards.
• Ability to communicate effectively in a cross-functional team environment.
• Ability to follow instructions in written, oral, or diagram form.
• Sound judgment and decision-making skills.
• Demonstrated attention to detail and thoroughness.
• Minimum of 2 years experience in a GMP regulated environment.

Benefits

• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Health Spending Account (HSA)
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Medical, dental & vision
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Short and long-term disability
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Employee Assistance Program

Training + Development

Interview process

Visa Sponsorship

Security clearance