QA Doc Specialist, 1st Shift

QA Documentation Specialist

Role and Responsibilities

The document control specialist will maintain the flow of both electronic and hard-copied controlled documents, department files and resource materials. Other responsibilities include writing document control systems and putting them into action, logging, tracking and maintaining batch records, coordinating document control issues between external subcontractors, service providers and fulfillment houses, and preparing reports regarding quality issues. The document control specialist must be able to recognize problems, recommend solutions and put the solutions into action. They must also be able to maintain confidentiality as they interact with all levels of an organization.

• Completes batch reconciliation.
• Reviews BOMs.
• Routes & logs raw materials test sheets.
• Manages raw material testing and approvals.
• Releases and approves raw materials in MAX.
• Creates, prints, verifies & logs raw material green tags.
• Releases, places material on hold or rejects finished goods in Access.
• Sends first production samples to customer for approval.
• Handles all Quality related FedEx & UPS shipments that leave the facility.
• Creates customer C of As, C of M’s.
• Creates, reviews & approves internal Fill and Assembly specifications.
• Maintains and distributes external documents.
• Maintains and tracks routing of internal and external documents.
• Retrieves archived documents for various departments and customers.
• Files documents.
• Maintains safety books.
• Other duties as assigned.
• Observes safety rules.
• Follows cGMP.

Qualifications and Education Requirements

• Must have High School Diploma
• 1-2 years of relevant experience preferred
• Great attention to detail
• Communication Skills: Strong communication skills are essential (able to read, write and speak English)
• Computer Skills: Excellent PC skills- Microsoft Office

Physical Requirements:

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility.  Must be capable of using a keyboard for computer purposes.