Welcome page Returning Candidate? Log back in! Quality Assurance Manufacturing Specialist I Job Locations US-PA-Philadelphia Job ID 2024-12952 Overview

Job Summary:  

Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues or improvements for new and existing clients, including being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances, deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release.

 

 

 

Responsibilities Review and approve low-risk non-conforming events (NCE), deviation and CAPA. Review and approve pre-executed batch records for assigned clients Review and approve executed Manufacturing batch records.Prepare Manufacturing release checklist and COA’sStay 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. Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records.Interact with QA batch record reviewers to communicate project requirements and assure that details are adequately translated into Manufacturing records.Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained. Revise SOPs as necessary.Review and approve document change requests.Participate in quality and process improvement initiatives, and project teams.Coordinate execution of Manufacturing Suite inspections.Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.Contact for on-site client visits.Maybe required to work Holidays and weekendsContributes to the overall operations and to the achievement of departmental goalsPerform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.Thorough understanding of Good Manufacturing PracticesOther duties as assignedPotential to be selected for Visual Inspection Qualification. Selected individuals are required to inspect final product in a light booth to detect defects and record the pass/fail results of their inspection Qualifications

Experience:

3 - 5 years or more of relevant experience or equivalentBachelor’s degree in a Science or equivalent experience

 

Knowledge / Skills / Abilities:

Knowledge of cGMP requirementsKnowledge of Root Cause analysis techniques required.Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.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.Ability to understand and follow verbal or demonstrated instructions.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.

 

Physical Requirements:  

Must be able to work in an office environment with minimal noise conditions.Must be able to work in Lab setting with Biohazards /various Chemicals  Must be able to wear appropriate PPEMust be able to work in environment with variable noise levelsAbility to stand /Sit/walk for long periods of timeClarity of VisionAbility to identify and distinguish colorsMust be able to perform activities with repetitive motionsAbility to climb Ladders / Stairs / ScaffoldingAbility to work in variable temperatures high to freezingInside/outside working conditionsIf selected to become qualified for visual inspection, the employee must pass an eye exam including corrected or uncorrected 20/20 vision, ability to pass a color blindness test, and ability to pass a depth perception test

 

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 Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Need help finding the right job? We can recommend jobs specifically for you! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Click here to get started.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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