Description
The Quality Control Supervisor will be responsible for technical management of personnel involved in the development, transfer, and troubleshooting of routine and complex techniques associated with daily QC release and provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. The Quality Control Supervisor will substantially contribute to overall process and method improvements within the Quality Control laboratory.Summary Description:
The Quality Control Supervisor will be responsible for technical management of personnel involved in the development, transfer, and troubleshooting of routine and complex techniques associated with daily QC release and provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. The Quality Control Supervisor will substantially contribute to overall process and method improvements within the Quality Control laboratory.
Essential Duties and Responsibilities:
Management of activities within the Quality Control Laboratory, specifically focused on personnel management and development, and the technical and compliance aspects of methods and techniques.
- Investigating and troubleshooting of Quality Control methods
- Review of QC Data for compliance to procedures and specifications
- Identifies deviations from QC methods and develops appropriate CAPA's
- Oversight of investigations related to OOS/OOT results
- Contributes substantially to the interpretation of results and subsequent impact to product/methods
- Oversight of transfer of methods from support groups to the QC laboratory
- Development and authoring of complex and explicit documentation for new and current procedures and technical reports
- Oversight of implementation of new technologies/instrumentation in the QC laboratory
- Transfer and development of new methods
- Implementation of new quality control procedures·
- Implementation and monitoring of personnel training related to new methods
- Technical guidance and resource in the QC laboratory
- Develop and retain staff
- Oversee management of reliable analytical testing and timely reporting raw materials, buffers, intermediates, and final product, and stability samples and monitor for Out of specification (OOS), Out of tolerance (OOT), Out of in-process limit (OOL) to ensure effective, thorough, and timely laboratory investigations.
- Oversee proper assay performance through data trending and metrics, immediate, effective response to laboratory errors and deviations and investigations
- Ensure strong Quality program for management of equipment and computer systems to ensure proper maintenance, calibration and conformance to regulatory standards
- Maintain procedures for accuracy and compliance. Draft/revise/review/approve/ qualify/ validate/ transfer quality control test methods
- EnsureQCtraining curriculum designs and conduct training. Assures the implementation of appropriate corrective actions in response to observations from Quality/ RA and System audits and/or third party assessments
Qualification Requirements:
- Bachelor's Degree in Life Sciences discipline and 6 years of experience in CGMP lab environment OR
- Master's Degree in Life Sciences discipline and 4 year experience in CGMP lab Environment
AND
- Background in Analytical Method Development and Validation
- Experience leading technical groups focused in Analytical Development.
- Experience managing scientific projects and personnel and presenting technical data
- Knowledge of CGMP, ICH, USP, and global compendial regulations and guidance's, particularly as related to analytical and bioanalytical method development and validation
- Experience with Scientific technical writing including authoring and revising SOPs or technical reports
- Experience troubleshooting assay and equipment issues
PREFERRED QUALIFICATIONS
- Experience managing in a Quality Control environment
- Strong leadership skills, driving accountability, compliance and efficiency
- Strong working knowledge of laboratory information management systems (LIMS).
To find out more about Real please visit www.realstaffing.com