Responsible for performing and validating analytical methods essential for quality control and release of drug product. Performs environmental monitoring of critical manufacturing areas, thus ensuring that manufacturing processes and products meet quality specifications, under general direction of managers and senior team members. The analyst shall maintain quality assurance processes, be responsible for testing products, recording and analyzing data during product development and manufacturing. The analyst will apply professional expertise on set processes and ensure adherence to best production practices and product quality standards, as well as monitors the efficiency and cost-effectiveness of product output. Interprets established procedures and exercises judgement to resolve issues of medium complexity.
Supervisory Responsibilities
None
Duties and Responsibilities
Perform and maintain test systems for GMP manufacturing, and responsible for performing assays related to in-production and post-production product quality.
Performs qualification/validation processes to maintain analytic validity of test methods.
Monitor aseptic manufacturing suites for contamination.
Maintain and monitor equipment and instruments, diagnoses and troubleshoots minor to medium complexity issues with laboratory instruments and equipment.
Monitor production processes for compliance with processes and procedures and participates in non-conformance and complaint investigations, and develops, coordinates and implements corrective and preventive actions.
Support other manufacturing work areas including supply chain staff in raw material inspections, maintenance of the supply records, supplier management program and recall activities, as needed.
Assists Quality Assurance staff in collating records for the final batch record review, as needed.
Perform and maintain environmental monitoring program
Other job duties as required
Education and Experience Requirements
A Bachelor's degree in a science related field.
Minimum of 3 - 5 years' experience performing and validating assays and/or working in a manufacturing quality control role.
Required skills and/or qualifications
Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing and testing is required.
Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
Exceptional human relations and communication (written, verbal, and listening) skills are required.
Should be very detail-oriented and have the ability to work independently and productively under general direction, and routinely exercise initiative and sound judgment to contribute to team objectives.
Strong analytic skills coupled with critical thinking skills are essential in this role.
Must have demonstrated capacity to write and comprehend complex protocols and reports, programs, and situations.
The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer.