Description
The Supervisor is responsible for assisting the QC Manager with the day-to-day operations for one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation) and environmental samples, as well as any assigned tasks including, but not limited to, troubleshooting, testing assignments, scheduling, training, document review, and special projects.
Requirements
Responsibilities: Responsibilities include, but are not limited to:
- Follow and ensure that the laboratory follows all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc.
- Lead person responsible for maintaining and troubleshooting laboratory equipment.
- Assist in training of laboratory personnel.
- Assist in the day-to-day scheduling, assignment, and coordination of testing/release of materials with Operations and Supply Chain.
- Assist in laboratory investigations (OOS, OOT, NCR, Product Complaint).
- Assist in laboratory documentation review for accuracy and completeness according to GMP, GDP, and data integrity requirements.
- Assist in the review and approval of the Certificate of Analysis for material disposition.
- Work with R&D to develop, improve, and transfer analytical methods for testing.
- Assist in the review and approval of specifications, analytical test methods, process and method validation protocols and reports, change controls, etc.
- Assist in testing materials, as needed.
- Coordinate and interact with all outside contract laboratories used for testing of samples.
- Ensure that all laboratory equipment is in a calibrated and qualified state as defined and required by SOPs.
- Assist with Metrology related functions, when needed.
- Other responsibilities as assigned by Senior Management.
Education and Experience:
- Bachelor’s degree in a science related field.
- At least 3 years of work experience in a Quality cGMP environment.
- At least 3 years of work experience in a laboratory setting.
Skills, Knowledge, and Abilities:
- Knowledge of laboratory chemistry or microbiology, and cGMPs.
- Proficient in Microsoft Word, Excel, PowerPoint, graphs/charts and databases.
- Experienced in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, wet chemistry, and microbial testing.
- Experienced in using analytical software programs, such as Empower.
- Knowledge of laboratory investigations and root cause analysis.
- Skilled in technical writing and data analysis.
- Able to effectively supervise people and give instruction to the department.
Physical Demands:
- Required to sit and stand for long periods of time.
- Frequently reaching with arms/hands up to 2 feet.
- Good hand eye coordination.
- Occasionally required to walk and kneel.
- Must be able to lift and/or move up to 50 pounds.
- Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus.
- Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls.
- Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs.
Work Environment:
- Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders.
- Potential to move between production operations sites/areas to complete job functions.
- Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
- Required to be present in the laboratory to perform daily testing and collaborate with department director and peers.
- Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.
Supervisory Responsibilities:
- Responsible for supervising nonunion employees.
Personal Protective Equipment or Attire Required for Position:
- Gowning as required by GMPs and/or SOPs.
