Summary /Objective
The primary function of a supervisor is the supervision of QC Chemists who perform qualitative and quantitative chemical and physical analysis in support of raw materials, in-process samples, components, and finished drug products testing. Additionally, a Quality Control Supervisor will be responsible for at least one of the following responsibilities as assigned by Quality Management:
- Scheduling work to meet the needs of manufacturing, packaging, and the Customer
- Management and timely completion of all OOS/OOT Investigations
- Oversight of the QC Laboratory Training Program, ensuring training is completed timely
- Support of the Technical Services Cleaning Validation Program
- Managing the flow of samples coming into the lab, testing of the samples, and destruction of samples
- Complete management of the Stability Program (Includes but is not limited to sample log-in, appropriate chamber placement, timely pulls, timely testing, report generation, and chamber functionality)
Essential Functions
- The QC Lab Supervisor has a complete understanding of the testing required of the QC Lab. They oversee and monitor the inspection and testing of components, raw materials, in process samples, finished product, and stability samples.
- A QC Lab Supervisor has strong oral and written communication skills to meet established policies and procedures. They are developing their interpersonal skill with interactions with others.
- A QC Lab Supervisor has a thorough understanding of Analytical Chemistry and can independently perform any testing required in the QC Lab.
- A QC Lab Supervisor has a thorough understanding of applicable cGMP, DEA regulations, and Quality Procedures for working in a QC Lab. Develops scientific and performance efficiencies for activities required for QC testing. Supervise product testing to ensure procedure accuracy and precision.
- Develops innovative approaches to technical issues. Trains others in problem-solving approaches.
- Supervise the selection of testing, recommend workflow improvements, and assess laboratory process issues. Leads within Dept as technology specialist.
- Assist in developing and implementing quality assurance programs and lifecycle approaches to meet production standards and customer requirements. Represents Department Chemists.
- Other duties as assigned
- Specialized - Dept. Tech Development
- Budget – Operate within dollar amount given. Impact on business
- Self and Group Development – Individual development of the groups
- Documentation – Prepares responses for the FDA requests with Management oversight
- Timelines – Supervisor schedules and oversees tasks within group to meet timelines
- Ethics – Has declarative and procedural knowledge of “Data Integrity and Ethics”
- Supervision
- Direct supervision of Chemist III, II, I and techs
Work Environment
This role operates in a professional laboratory and office environments; business casual/casual attire is required. This role requires the use of standard office equipment such as computers, phones, and photocopiers.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must regularly lift and/ or move up to 50 pounds. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand, walk, sit and talk or hear. The employee is occasionally required to climb or balance, stoop, kneel, crouch, crawl and smell.
Required Education and Experience
- BA/BS in Chemistry or related Scientific field plus minimum 8 years in a pharmaceutical QC Lab
- Supervisory experience or course(s) in Supervision
- Organized and detail oriented
- Highly accurate and efficient
- Abstract problem-solving skills
- Strong communication skills
PREFERRED EDUCATION AND EXPERIENCE
- BA/BS in Chemistry or related Scientific field plus minimum 8 years in a pharmaceutical QC Lab
- MS in Chemistry or related Scientific field plus minimum 6 years in a pharmaceutical QC Lab
- Supervisory experience or course(s) in Supervision
- Advanced excel skills
WORK AUTHORIZATION/SECURITY CLEARANCE (IF APPLICABLE)
- Authorized to work in the US
- DEA background clearance