JOB QUALIFICATIONS:
- Bachelor's degree in chemistry or related field
- 5+ years Pharmaceutical analytical data review experience preferred
- Solid knowledge of cGMP, GLP, GDP concepts Federal Regulations
- Previous experience conducting Analytical data review
- Working knowledge of cGXP, Data integrity, ALCOA principles
- Review of standard testing procedures (STM), general procedures, excipients COAs, packaging components COAs
- Operational understanding of laboratory equipment and pertinent software (Empower/LIMS)
- Critical thinking, problem solving, and analytical thinking applied to data and diverse situations
- Excellent interpersonal communication skills: verbal and written skills
- Able to work multiple priorities in parallel
- Computer proficiency: Word, Excel, and Power Point
Position Responsibilities:
- Final review of analytical data including, but not limited to raw materials, finish products, and stability data including method validation/ verifications
- Ensures that analytical data is in compliance with GMP, GLP, and GDP
- Manage routine minor corrections with the Lab Chemist
- Communicates any Out of Specification (OOS) or Out of Trend results (OOT) identified during data review to the QC Manager or Quality Director
- Informs the QC Manager or Quality Director of any critical data integrity issues or data irregularity
- Support other tasks that might be oriented by the QC Manger or Quality Director
Physical Requirements:
- Adhere to all safety policies; includes wearing personal protective equipment when required
- Ability to work standing/walking 50% of the time
- Ability to occasionally: lift 10-50lbs, carry 10-50lbs and to stand, bend and stoop