Job description

The Document Control Technician is directly responsible for the daily Document Control functions in the Electronic Document Management System.

Major Roles & Responsibilities:

• Coordinates the document review and approval process through the daily Document Control functions in the Electronic Document Management System as outlined below.
• Initiates new documents as requested by system editors, including new Infocard creation and generation of document template.
• Performs formatting of documents in accordance with system requirements and company expectations (i.e. margins, pagination, spelling/grammar).
• Schedules document effectivity in the system ensuring the document is published and available in the system as required.
• Initiates process for document archival when requested by system editers.
• Issues facility logbooks when requested and ensures existing logbooks are closed out upon issuance of new.
• Tracks facility logbooks by location and volume issued. Ensures new logbooks are issued with the correct volume.
• Tracks status of in-process tasks in the system to ensure documents are actively being reviewed, approved and scheduled effective.
• Assists with filing of company records and documents as needed, including scanning, filing and retrieval of filed items when requested.
• Assists in the completion of data entry and analysis as needed for the Quality and Regulatory Department.
• Assists in coordination of CAPA closures and files CAPA closure document with applicable investigation reports.
• Supports the Electronic Documentation System and users by unlocking accounts, maintaining user rights and training new users on the system.
• Formats documents in accordance with BioSpectra policies.
• Assists with routing of Quality System Documentation for approval including Change Controls, Complaints and Investigations.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• 2-year Associates Degree or approved equivalent experience in a cGMP environment * Understanding of cGMP & ICH-Q7
• Strong knowledge of relevant software applications including MS Office and Minitab * Knowledge of office systems and procedures
• Organized, Thorough, Neat
• Must be able to read, write, speak, and understand English
• Confidentiality
• Ability and willingness to work from all BioSpectra facilities

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Repeating motion that may include wrists, hands, and fingers

Job Type: Full-time

Pay: From $18.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• On call

Ability to commute/relocate:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Microsoft Office: 1 year (Preferred)

Work Location: One location

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