Scientist - Compliance and Support

DUTIES AND RESPONSIBILITIES

Performs and documents compliance reviews of analytical data, reports, and documentation related to batch release. Performs and/or coordinates other compliance/support activities. Performs responsibilities in accordance with written procedures and/or under the direction of the supervisor. Demonstrates ability to recognize, identify, and resolve problems. Demonstrates the ability to work independently based on training and experience.

* Performs and documents compliance reviews of technical reports, data, and batch release documentation in accordance with written procedures and/or under the direction of the supervisor.
* Performs and/or coordinates other compliance activities and systems in accordance with written procedures.
* Performs and documents compliance reviews of department systems.
* Performs, routinely or as backup, compliance/support activities such as reference standard program, sample administration, training documentation, record archiving, chemical receipt.
* Maintains current knowledge of FDA, USP, and ICH requirements and guidelines.
* May assist in the development and training of peers and less skilled employees.
* Participates at appropriate meetings.
* Completes tasks on schedule with minimum supervision.

REQUIRED EDUCATION/EXPERIENCE/SKILLS

* MS in Chemistry, or equivalent, with minimum 5 years relevant pharmaceutical experience or BS degree in Chemistry, or equivalent, with a minimum of 8 years relevant pharmaceutical experience.
* A working understanding of GMPs and regulatory guidances.
* Experience with analytical instrumentation, particularly chromatography.
* Experience in performing technical and/or compliance reviews.
* Experience in reviewing documentation for release of batches desirable.
* Possess strong analytical, communication, organizational, and interpersonal skills.
* Detail and quality orientation.
* Proficient in the use of a word-processing and spreadsheet program.

DEY supports diversity in the work place. We are an Equal Opportunity Employer.