QC Supervisor

Alora Pharmaceuticals

Fort Worth (TX)

On-site

USD 110,000 - 140,000

Full time

3 days ago

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Job summary

Alora Pharmaceuticals in Fort Worth, TX is seeking a QC Lab Supervisor to oversee qualitative and quantitative testing in support of drug products. You will supervise QC chemists, manage OOS/OOT investigations, and ensure training and adherence to cGMP and DEA regulations.

Requirements include a BA/BS in Chemistry or related field with 8+ years in a pharmaceutical QC lab, supervisory experience, and strong analytical and communication skills.

Qualifications

BA/BS in Chemistry or related scientific field with at least 8 years in a pharmaceutical QC lab.
Supervisory experience or coursework in supervision.
Strong organizational and detail oriented.
Highly accurate and efficient with abstract problem-solving skills.
Strong communication skills.

Responsibilities

Oversee QC lab testing of components, raw materials, in-process samples, finished products, and stability samples.
Schedule work to meet the needs of manufacturing, packaging, and the Customer.
Manage the timely completion of all OOS/OOT investigations.
Oversee the QC Laboratory Training Program and ensure timely training.
Support of Cleaning Validation and QA programs.
Supervise testing workflows and drive process improvements in the QC lab.
Ensure compliance with cGMP, DEA regulations, and quality procedures.
Coordinate development and implementation of quality assurance programs.

Skills

Strong communication skills

Analytical Chemistry understanding

Problem-solving skills

Leadership

Education

BA/BS in Chemistry or related scientific field

MS in Chemistry or related scientific field

Supervisory experience or supervision coursework

Tools

Excel (Advanced)

Job description

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