SUMMARY
As the Quality Analyst III, Chemistry for an aseptic, sterile vial fill and finish manufacturing and packaging facility, you'll be responsible for quality review and approval of protocols, reports, change controls, investigations, CAPAs and other compliance activities (i.e. APRs, stability reports, tech transfers) related to the quality control chemistry laboratories. You will be a key team member of the QA team, responsible for QA oversight of laboratory compliance including (but not limited to) review and approval of investigations, method validations/transfers, change controls, stability management. Under limited guidance, supports and ensures the compliance operations in the laboratory. Partners with the laboratory and other supporting departments for problem resolution.
KEY DUTIES
- Execute and interpret key metrics and trend charts using data and/or statistical analysis in support of Annual Product Review and Quality Metrics
- Drive quality risk assessment as well as effectiveness checks as part of Change Control and CAPA processes
- Demonstrate effective leadership and teamwork to junior and senior level Quality personnel
- Comply with all company policies and procedures, including safety rules and regulations, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging operations.
QUALIFICATIONS
- Bachelor's degree in Chemistry or related field, at least 4 years of quality engineering or related QA experience in a cGMP manufacturing environment, and 8 years in pharmaceutical manufacturing or a similar environment
- Experience in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging environment
- Experience in method validation, method verification, method transfers
- Strong understanding of compendia compliance
- Experience of Root Cause Analysis (5 Whys, 6M's, Is/Is Not, FMEA, etc) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence
- Experience in Auditing techniques in a cGMP facility, strong understanding of GLP
- Knowledge of Lean/5s application
- Need experience in TrackWise, LIMS, EDMS, SAP
