Quality Assurance Professional
6 days ago
This role is located in Wilmington, OH.
Job SummaryWe are seeking an experienced individual to support daily manufacturing and facility operations, as well as project support. Responsibilities include proactive support of change control assessments, documentation reviews, and validation review/support. Additionally, reactive support of discrepancy identification and resolution on the floor, investigation team support, TrackWise (assessing product impact), and reporting operational metrics are required. This function supports and communicates events to shift leadership on a daily basis.
Qualifications and Skills- Bachelor's degree in a scientific discipline desired.
- Minimum 2-5 years related experience in a Quality Assurance role in the pharmaceutical industry.
Technical Knowledge/Skills Needed:
- Strong written and oral communication skills.
- Basic introduction/understanding of the regulatory process from development through commercial manufacturing.
- Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues.
- Familiarization with oral solid dose manufacturing qualification and quality.
- Experience in change management and investigation resolution, including Deviation and CAPA systems.
- Basic knowledge of US Drug Product GMP requirements and associated guidelines.
- Demonstrated experience in implementation and administration of quality systems for drug product manufacturing.
- Project management experience, including scheduling, tracking, and auditing.
Personal Attributes Needed:
- Team player committed to quality; motivated self-starter; detail and results-oriented; well-organized, efficient worker with good communication skills.
- Innovative thinker and problem solver.
- Flexible and can embrace change.
- Can manage and prioritize multiple duties and tasks.
- Ability to increase others' knowledge of US and European GMP regulations and guidance.
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