Quality Assurance Manufacturing Specialist I

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 PM

Schedule : 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

• Review and generate of Environmental Summaries to support batch release
• Review and approve disruption of controlled environment (DCE) documentation
• Ensure good aseptic processing practice by manufacturing during shop floor support
• Perform visual inspection of finished products for designated clients
• Review and approved executed batch records
• Review and approved deviation, non-conformance event (NCE) and change control
• Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP
• Prepare manufacturing Certificate of Analysis for batch release
• Generation of Manufacturing batch records
• Archiving of executed batch records and associated documentation
• Approval of document change requests (DCRs)
• Release of raw materials to support manufacturing operations
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie : ICH, ISPE, etc.).
• Interact with manufacturing management to provide quality perspective on routine operations and support systems. Address conditions / practices with appropriate personnel, documents and reports findings to Management.
• Participate in quality and process improvement initiatives, and project teams.
• Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
• Required to work on holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals

Qualifications

• 4 years or more of relevant experience or equivalent
• Bachelor’s degree in a Science related major

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.