GENERAL DESCRIPTION:
To fulfill the requirements for provision of Quality Control (QC) functions as outlined in cGMP standards.
QUALIFICATIONS:
QC Specialist will have experience in an environment regulated by FDA and cGMP standards. Experience in other quality standards such as GLP or GCP will also be considered.
Experience with document control, batch records, SOP generation and auditing is preferred. A B.S. degree in a general science field is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required.
The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality control responsibilities. Communication skills, especially written, are necessary. Proficiency in MSWord and Excel is required.
SPECIFIC RESPONSIBILITIES:
• Assist in performance of all Quality Control functions as required under cGMP and outlined in PSL SOPs. Assist the Laboratory Director and Quality Assurance Director as needed during inspections by FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained.
• Assist in the maintenance of the ISO/IEC 17025 accreditation. GMP QA Specialist will know very little in nothing about ISO.
• Conduct inspections and general facility audits in the GMP and/or GLP parts of the facility as directed.QA function, not QC
• Audit raw data and proofread reports and tables against raw data for accuracy and for typing corrections. QA Batch Review, etc., where the batch record has been generated by QC and/or manufacturing individuals Audit final report to verify corrections.
• Amend and update Standard Operating Procedures as required using a word processing system. File all QC-related paperwork as directed.
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• Ability to safely wear a respirator is required.
Other duties as assigned