Quality Assurance - Compliance Investigator
About The Position
Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventive actions to ensure compliance. Essential Functions and Responsibilities Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations.Drive investigations to true root cause using appropriate investigation tools.Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.Define and manages implementation of effective preventative actions to prevent recurrence.Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.Collaborate with cross-functional teams to develop and track CAPA plans.Identify and create appropriate trending rules that trigger corrective actions.Analyze process data and evaluate trends to identify major improvement opportunities.Effectively utilize change management approach.Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation process.Manage CAPA plans and implementation.Provide communication plan for on-going deviations & CAPA’s.Effectively create and communicate CAPA plan to responsible parties.Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.Ability to abide by quality standards. Other duties as assigned
Requirements
- Bachelor of Science in a Quality / Process related field or equivalent experience.
- 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience.
- Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
- Must have technical experience writing and assessing deviations, investigations, and Out of Specifications
- Must be able to analyze data/information and to assess and resolve complex problems
- Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing
- Knowledge of operational processes and controls in non-sterile and sterile operations
- Experience using e-Quality Management Systems preferred.
- Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Strong written and oral communication skills
- Flexible and able to adapt to company growth and evolving responsibilities
- Integrity, accountability, and strong dedication to regulatory compliance
- Continuous improvement mindset
- Ability to work effectively as a team and independently
Nice To Haves
- Experience using e-Quality Management Systems preferred.
Responsibilities
- Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations.
- Drive investigations to true root cause using appropriate investigation tools.
- Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
- Define and manages implementation of effective preventative actions to prevent recurrence.
- Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
- Collaborate with cross-functional teams to develop and track CAPA plans.
- Identify and create appropriate trending rules that trigger corrective actions.
- Analyze process data and evaluate trends to identify major improvement opportunities.
- Effectively utilize change management approach.
- Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation process.
- Manage CAPA plans and implementation.
- Provide communication plan for on-going deviations & CAPA’s.
- Effectively create and communicate CAPA plan to responsible parties.
- Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
- Ability to abide by quality standards.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
