Qa Analytical Data Reviewer/Auditor

:

• Review and audit in-process, finished product/release and stability testing of dosage forms as per approved methods.
• Review and assist in product complaint investigations.
• Assist with the CAPA and Change Control Systems.
• Assure that all activities are documented in assigned laboratory notebooks as per Saptalis procedures and cGLPs.
• Audit the laboratory routinely and assure that all personnel are trained and all testing equipment is with in calibration and laboratory operates with GMP compliance at all times as per FDA regulations and Saptalis SOPs.
• Assist in conducting OOS, OOT and other Quality investigations to determine root cause for failure results and implement corrective actions.
• Review analytical laboratory data packages and laboratory notebooks and assure that all testing is performed as per GLP requirements and Saptalis SOPs.
• Review and approve cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents.
• Review audit trails on data acquisition systems, equipment calibration status and assure that data integrity is maintained at all times.
• Collaborate with departments and external suppliers regarding quality concerns.
• Develop and maintain metrics and trending reports for Compliance-related activities.
• Review and audit release testing of raw materials and packaging components as per compendia or approved methods.
• Review analytical methods, method validation protocols, method validation reports, method transfer protocols/reports, cleaning validation protocols, reports and methods, raw material specifications, product specifications, SOPs and other GMP technical documents.
• Assist Management team during Pre-Approval and general GMP inspections by the USFDA and external auditors.

Qualification:

• Knowledge of HPLC/GC principles and ability to review data for accuracy and completeness
• Ability to work well under pressure and maintain efficiency both on an individual and team basis
• Ability to work well in a team-oriented environment
• At least 2-5 years of testing and data review and cGMP experience
• Ability to multi-task with high efficiency
• BS/MS Degree (preferred in chemistry or equivalent)
• Well-developed communication and technical writing skills
• Experience in quality systems auditing (internal and/or external) preferred
• Knowledge of cGMP regulations and validation principles
• Ability to assess problems, to identify solutions, to plan and implement necessary changes

Position Benefits:

• Works cross-functionally and receives exposure to several departments.
• Medical, Dental, Vision and 401K plans are offered.
• Potential for career growth within an expanding QA/QC team as well as other areas.