General Position Summary/Purpose:
Performs and maintains QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug products manufactured at CMOs.
Key Accountabilities/Core Job Responsibilities:
- Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug products (DP) under clinical development in compliance with US FDA and international health agency requirements.
- Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
- Coordinates leads and conducts internal Quality Investigations as well as investigations at contract manufacturing organizations (CMOs).
- Performs person-in-plant (PIP) during manufacturing campaigns of DP at CMOs.
- Reviews and approves change control requests to ensure compliance with Company procedures, cGMP, and other applicable regulations.
- Represents QA and provides support to the internal CMC team.
- Lead compliance internal audits.
- Provides and prepares quality metrics as needed.
- Initiates updates and creation of new SOPs as required.
- Serves as Quality Representative for regulatory inspections as needed.
Qualifications and Requirements:
- Minimum BA/BS Degree in biological sciences, chemistry, or related field.
- 3 - 7+ years of pharmaceutical experience in a GMP quality (QA/QC) environment.
- Excellent working knowledge and understanding of GMP related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.
- Detail oriented with Quality Assurance background with solid problem solving acumen. Ability to work effectively in a team environment with great organization skills.
- Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.
- Ability to analyze and reconcile moderate to complex issues independently.
- Must be an individual with proven initiative and demonstrated accountability in a fast paced environment with high degree of flexibility.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e. 2007 Microsoft Office products).
- Required 10% travel.
Pharmacyclics, Inc. - 16 months ago