Job Description

The QA Document Specialist is responsible for handling and reporting complaints, issuing device history records, maintaining all current Good Manufacturing (cGMP) documentation and other miscellaneous duties as assigned by Sr. Manager of Regulatory and Quality.

Essential Functions

Maintain the hard copy of documents as well as the electronic database of all Standard Operating Procedures (SOP), Specifications (SPEC), Test Methods (TM), Protocols and Validation documentation. This includes converting all documentation to PDF format.

Review documents submitted for approval routing to ensure correct formatting, pagination, headers, attachments, forms, etc.

Assist with the review, revision, and development of documents.

Maintain database of electronic forms of effective documents that are used by employees for the collection for quality data.

Organize and maintain the document storage area.

Maintain both computerized and hard copy document systems including Device History Records (DHR), Corrective and Preventive Action (CAPA), Nonconformances (NR), Deviations, Engineering Change Control (ECR), etc.

Address customer complaints, maintain hard copy and computer files of these records, and organize the replacement of defective products.

Assist with trend analysis of customer complaints, production scrap, finished device inspection, etc.

Issue product Device History Records (DHRs) for production of finished devices.

Review completed DHRs and release finished device lots.

Maintain both computerized and hard copies of training records.

Maintain the electronic database of Approved Supplier List (ASL) as well as their associated files.

Assist with the monitoring of the hazardous waste accumulation area.

Serve as a back-up for finished product (QA) testing as well as line clearances during production.

Other Duties and Responsibilities

• Report all unsafe activities to supervisors and/or management.
• Participate in proactive team efforts to achieve departmental and company goals.
• Comply with all company safety policies, practices, and procedures.

Qualifications

Education

High School Diploma to Associates degree or commensurate experience required.

Background/Training/Skills/Experience

• 1-3 years of administrative or customer service experience.
• Strong verbal and written communication skills required.
• Strong interpersonal skills.
• Extremely organized and able to provide information quickly.
• Technically proficient in Microsoft Office Products and personal computer skills.
• Must be highly organized, accurate, and detail-oriented.
• Must be able to handle multiple projects simultaneously.
• Knowledge of cGMPs in the Medical Device and/or Pharmaceutical industry.

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