Analytical Quality Assurance Specialist
About The Position
Analytical operations that are conducted under the requirements of cGMP require oversight by Quality Assurance. This oversight will be directly provided by the Analytical Quality Assurance Specialist. This oversight will include the review and approval of methods, procedures and protocols and the review of data and results supporting reports, Certificates of Analysis (C of As), qualifications, validations, investigations and deviations. The compliance of the analytical facility and laboratories will be ensured through routine inspections. The specialist will support the timely completion of quality related items that support the cGMP analytical operations for AMPAC Analytical laboratories.
Requirements
- Bachelor’s degree in an appropriate science
- 3 years of related technical experience in analytical chemistry
- 2 years of experience in a GMP regulated laboratory environment or an equivalent combination of education and experience.
Responsibilities
- Ensuring that adequate QA support is provided for cross functional team meetings and Customer teleconferences
- Communicating the status of QA related items to the respective project teams and as needed ensure timely completion of QA related action items.
- Taking an active role providing, as appropriate, guidance within the approved systems and procedures as it related to cGMP analytical operations, some of this guidance may be required outside of the typical working schedule (off shift)
- Taking an active role in planning and execution of action items related to support of analytical operations, including but not limited to the review and approval of procedures, protocols, methods, reports, qualifications and C of As, etc.
- Review of and/or conduct investigations for deviations to procedures and testing (i.e. VAR, OOS/OOT investigations, QCRs, etc)
- Review and as appropriate the management and approval of quality system items that relate to the analytical operations (i.e. CAPA, Change Controls, pest control and temperature monitoring data, etc)
- Responsible for routine audits of the respective analytical facilities and laboratories to ensure compliance with procedures and cGMP including the documented review of facility and equipment logbooks.
- Timely support of the customer’s Quality Assurance requirements including participation in routine teleconferences and customer onsite visits. Support the review and approval of those requirements via mutually agreed upon quality agreements
- Support as needed any Quality Systems or additional Quality Assurance functions for which you have adequate training
- Responsible for the development and reporting of appropriate metrics for review by management
- Responsible to obtain and maintain appropriate training for the requirements of this role
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
