Sr. QA Specialist
- Lead investigations on consumer complaints preventing past due reports.
Trend consumer complaints for process improvements.
Work with other QA management team to write APR reports.
Ensure reports/documentation meet quality standards.
Manage APR schedule ensuring report due dates are met.
Review the APR process for improvements, increasing efficiency and ensure compliance with expectations.
Communicate and interact with customers to resolve issues and address concerns.
Perform a statistical analysis of report data to identify trends.
Complete internal audits, determine audit dates, organize personnel and lead all internal audit efforts, completing all audit documentation.
Initiate corrective actions as needed.
Review internal audit process for improvement.
Manage the CAPA process to ensure action items are being completed efficiently/timely.
Assist with the scheduling and lead change management review board, engaging area owners in the review, assessment, and disposition of initiated change controls. Ensure the correct SMEs are selected as reviewers.
Prepare data for management review on change request trends and metrics.
Determines actions and implements corrections and improvement in the change control process.
Manage change control documentation through appropriate means.
Generate the weekly QA Metric Report for distribution to upper management.
Knowledge and Skill Requirements:
- Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team.
- Strong organizational, problem solving, and analytical skills.
- Strong overall understanding of pharmaceutical/FDA regulated Quality systems.
- Ability to lead and motivate teams.
- Ability to work (and multi-task) in a fast paced environment.
- Ability to work comfortably in electronic data management systems.
- Ability to work comfortably with data and excel spreadsheets.
- Very detail oriented.
- Possess excellent multi-tasking skills.
- Knowledge of current GMP required.
- Excellent written/oral communication skills.
- Capable of making independent decisions and assessments related to impact of product and Quality systems.
Education and Experience:
- Bachelor’s degree in a scientific field.
- 5+ years working in Quality for FDA regulated manufacturing environment.
- At least 3 full years writing, reviewing or compiling data for Annual Product Review Reports.
- Experience with statistical trend analysis and pulling data from electronic systems.
- Auditor qualification certificate or documented auditor training.
- At least 3 full years approving process / equipment change controls requests.
- Working under minimal supervision and capable of making independent decisions.