Wuxi Apptec Philadelphia , PA 19107
Posted 3 weeks ago
Overview
This position is required to work on shift and be on-site.A Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. High level job accountabilities included activities related to sterility assurance, manufacturing oversight, quality system and release of raw materials.
Hours: 12 PM to 10 PMSchedule: Sun-Wed or Wed-Sat (must be open to working either of these schedules as business needs require)
Location: 100% In-person at our Philadelphia site
Responsibilities
Qualifications
Knowledge / Skills / Abilities:• Knowledge of Root Cause analysis techniques required.• Experience in writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA's preferable.• Sound knowledge of FDA and EU cGMP requirements• Works on complex issues with Quality management where analysis of situations or data requires an in-depth evaluation of variable factors• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).• Ability to record data accurately and legibly.• Ability to use judgment as dictated by the complexity of the situation.• Good oral and written communication skills.• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.• Proficient in Microsoft Office (Excel, Word, PowerPoint, Visio)
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Wuxi Apptec