Our client is currently seeking a Quality Control Supervisor/Manager to join their Quality Control team in Rockville, MD.
This quality control manager role is responsible for supervising the day to day operations related to the Quality Control Biochemistry group. This is an exciting opportunity for the QC professional that is ready to advance their career.
- Lead and direct the day to day operations of the QC Analytical Biochemistry group
- Manage testing of critical reagents, in-process, release and stability samples
- Review and compile laboratory test data and perform appropriate analyses
- Ensure that data is reviewed and authorized in a timely manner
- Ensure GMP compliance within the group
- Lead laboratory investigations to determine root cause
- Facilitate the maintenance of the lab including routine housekeeping, lab inventory, and equipment
- Identify and troubleshoot equipment and software problems
- Quickly identify and resolve gaps and provide guidance while troubleshooting complex problems
- Professionally develop analysts to improve on individual and overall performance
- Ensure that suitable written records and work undertaken are kept in accordance with cGMP and company procedures
- Assist with the writing, reviewing, and editing of standard operating procedures, laboratory protocols, and technical reports
- Contribute to the management of deviation documentation, investigational reports, change control and CAPAs, which includes writing, reviewing and approving associated documentation
- Investigate out-of-specification and recommend corrective actions
- Participate in internal assessments and regulatory audits as required
- Evaluate new biochemistry methods and equipment
- Contribute to team building, training and problem-solving initiatives internally and cross site.
- Bachelor's degree in a scientific discipline. 2-8 years of supervisory experience
- Minimum of 4 years' experience in a cGMP laboratory, preferably related to pharmaceutical industry operations
- Detailed experience with HPLC, UV-Vis, and SDS-PAGE methodologies
- Knowledge of FDA regulations regarding the manufacturing of biologicals
- GXP (regulatory relevant skills and knowledge) GCLP/GCP/GMP
- Ability to comprehend regulatory requirements and technical documentation and objectively make decisions
- Excellent verbal and written communication skills
- Working knowledge of LIMS preferred
- Experience with Technology Transfer of analytical methods is a plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.