Supervisor, QC Laboratory

Adare Pharma Solutions•Vandalia, OH

1d•Onsite

About The Position

The Supervisor, Quality Control Laboratory will oversee QC laboratory operations and align resources with testing needs. This position is the primary point of contact for Manufacturing and other departments for the respective shift. Perform the most complex chemical testing of intermediate and finished products according to written procedures and maintain QC instrument operation and reliability. Position requires instrument troubleshooting and method optimization to enhance lab throughput along with training others on current test methods and assists with implementation of new methods.

Requirements

Bachelor’s degree in Chemistry or closely related field and 5+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry.
M.S. in Chemistry or closely related field and 3+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory in the pharmaceutical industry.
Experience managing a team
Excellent written and oral communication skills
Organized with exceptional attention to detail
Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices which also includes lab networks and data integrity practices
Knowledge and application of regulations relating to product stability
Able to work independently on multiple projects in a dynamic and fast-paced environment
Possess computer skills including Microsoft Office applications
Able to contribute to cross-functional teams
Possesses initiative with a proactive attitude to problem-solving, and has a desire to learn new skills

Responsibilities

Responsible for managing the communication between their respective shift and other shifts as well as management concerning daily activities in the Quality Control lab.
Responsible for managing the communication with other departments (MFG, Maintenance, R&D)
Completes performance reviews and assist Manager in providing input for performance reviews of other personnel not on their shift
Sets priorities for the shift and allocates work within the shift to ensure priorities are completed on time
Responsible for auditing data when necessary
Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
Perform more advanced troubleshooting/maintenance of the instrumentation
Responsible for more complex physical and chemical testing of intermediate and finished products as described in the documented procedures to support product release and process validation protocols
Demonstrate proficient ability to operate the instrument software applications, troubleshoot software and report data
Perform swabbing and analysis of more complex manufacturing equipment in accordance with cGMP guidelines. Provide input on cleaning related issues and investigations
Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines
Assist Management with writing and completion of investigation sections and product impact as required.
Train others as required as it pertains to LIR/OOS procedures
Train other Chemists on current and new test methods
Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures.
Peer review and/or audit others work as required for verification of GMP compliance
Auditing of laboratory testing data as required
Perform cost savings and process improvement projects as required
Perform other duties as required