Quality Assurance Specialist - Quality Systems

The QA Specialist – Quality Systems is responsible for document control, including creating, reviewing and issuing cGMP procedures. This position also assists in maintenance and implementation of quality systems to assure compliance with FDA cGMP and other quality standards, with prime responsibilities to include oversight of deviations and CAPA, failure investigations, tracking and trending of quality data. The QA Specialist also maintains quality system procedures, conducts internal and external audits as required.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Biology, Chemistry or related field of study required
• 3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred
• 3 – 5 years of experience in QA and document control preferred

TECHNICAL SKILLS REQUIREMENTS

• Attention to detail
• Good organizational skills
• Good communication skills
• Strong computer skills

PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit; climb or balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. The employee must meet visual acuity requirements including color, depth perception, and field of vision.

POSITION RESPONSIBILITIES

• Administer QA/QC documents including SOPs, test sheets, batch records, validation protocols/reports, annual product reviews.
• Administer the Quality Management software system including change control, deviation, CAPA and document control.
• Provide software/database/spreadsheet validation support.
• Administrator of Approved Vendor/Supplier list.
• Assist and notify Contract Manufacturers regarding their product.
• Assist QA Manager with FDA/Contract Manufacturer audits.
• Back-up Document Coordinator when needed (review/audit batch records, issue batch records).
• Issue logbooks and logbook pages.
• Track status of manufacturing investigations, laboratory investigations, customer complaints, process changes and CAPAs.
• Issue Certificates of Analysis as back up.
• Perform other quality system duties as required to support FDA cGMP compliance such as other quality projects and manufacturing site initiatives.

Huvepharma will not accept unsolicited resumes from Staffing Agencies, Placement Services or Professional Recruiters.