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Overview

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Laboratory Investigations Department for an Investigation Analyst.This position is responsible for performing OOS (Out of Specification) Client Investigations and assisting in the timely completion of CAPA (Corrective Action and Preventive Action) Investigations and sub-systems (e.g. NCE, complaints).

Responsibilities

Essential Job Functions:

• Perform OOS Investigations as requested by clients and QA.

• Communicate with clients regarding the investigation as necessary.

• Partner with departments to participate in Quality, PAR, CAPA, ACAR investigations

• Track LIRs, NCEs, address client complaints, and assist with completion

• Track implementation and training resulting from CAPA, and assist with training

• Communicate with clients regarding technical and nontechnical questions pertaining to the investigation status.

• Train in multiple laboratories to receive working knowledge of testing.

• Special Projects, as needed.

• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

• Normally receives minimal instructions on routine work and detailed instructions on new assignments.

• Works under close supervision from supervisor or senior personnel.

• Ability to work in a team environment and independently as required

• May be required to work Holidays and weekends

• May be required to work overtime

• Contributes to the overall operations and to the achievement of departmental goals

• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

• May be required to assist in other departments

• Other duties as assigned

Qualifications

Experience / Education

• Associate or Bachelor’s degree in Science

• Minimum 2 years of experience in related discipline or 4 years without degree

• Scientific technical knowledge and/or QA experience working within a regulated industry

• Prefer experience working with CAPA process

Knowledge / Skills / Abilities:

• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices

• Excellent organizational skills & high attention to detail

• Ability to work independently and with teams

• Ability to analyze and interpret data

• Good written communications

• Proficient in Oral & Written communication skills

• Need to be able to read, write and understand English

• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.

• Must be able to work in Lab setting with exposure to biohazards / chemicals

• Must be able to wear appropriate PPE

• Must be able to work in environment with variable noise levels

• Ability to stand / sit / walk for long periods of time

• Ability to identify and distinguish colors

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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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 disabilityAn 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 (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)

Job Locations US-GA-Marietta, Georgia

Job ID 2024-12984