Quality Documentation Specialist
A specialized medical development company, located north of Pittsburgh, is seeking a Quality Documentation Specialist.
- Assists Quality System/Regulatory Compliance (QS/RC) and Analyst(s) to ensure external and internal Customer requirements are met according to documented and communicated policies and procedures.
- Based on established procedures, is responsible for the review and approval of processing files prior to product processing. The review ensures accurate product codes for numbers, case count, and cycle specifications.
- Responsible for the review of processing files after product processing, and prior to product release, in order to ensure processing parameters have been met.
- Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning, aeration and maintenance) to ensure timely and accurate record keeping processes.
- Assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.
- Assists in the establishment of appropriate policies and procedures, as well as revision and maintenance of the Quality System.
- Assists with writing deviations and documenting customer concerns based on established customer specifications and QS/RC policies and procedures.
- With direction from the QS/RC Manager or Analyst, assists with corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, customer audits, and internal audits.
- With direction from the QS/RC Manager, prepares the monthly internal assessment report.
- Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions to facility management.
- HS Diploma and/or AS Degree and a minimum of 2 years of related quality experience
- Must have an understanding of ISO 9001 and 13485 standards
- Knowledgeable of Good Manufacturing Practices (GMP’s), FDA and OSHA standards
- Must have good computer skills; proficiency with MS Office (Word and Excel)
- Must have good math skills
- Excellent communication skills, both written and verbal
- Strong attention to detail required
Hours: Monday-Friday, 10:00am-7:00pm