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Associate Quality Assurance Specialist

Company: WuXi AppTec Inc
Location: Saint Paul
Posted on: May 12, 2022

Job Description:

Overview:
The Associate Quality Specialist is responsible for ensuring GLP studies, GMP testing, and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies and internal procedures.Please note the work schedule for this opening is Tuesday-Saturday, days/first shift.

Responsibilities:
Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.Performs audits (critical phase and manufacturing) and appropriately documents the findings. Reviews final reports (GLP), batch records (cGMP), Certificates of Analysis (GMP), and/or other necessary documentation, as appropriate to the defined Quality Role within the applicable regulation(s).Assists with internal audits, as requested.Performs QC review activities, where applicable.Assists in identifying and initiating QA CAPA activities (deviations, lab investigations, OOS).Ability to work in a team environment and independently.May be required to work weekends.May be required to work Holidays.Contributes 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 Laboratory Practices and Good Manufacturing PracticesMay be required to work OvertimeOther duties as assigned May be required to assist in other departments

Qualifications:
Experience / Education:Minimum 0 years of experienceBachelor's Degree or equivalent Scientific background preferredKnowledge / Skills / Abilities:Proficient Oral & Written communication skillsNeed to be able to read, write and understand English Proficient in Microsoft (Excel, Word, Outlook)Physical Requirements:Must be able to work in a Lab setting with exposure to animals/biohazards/chemical (list chemicals)Must not have animal allergies to applicable species in this facility Must be able to wear appropriate PPEMust be able to work in environment with minimal noise levelsAbility to sit/stand for long periods of timeClarity of visionAbility to identify and distinguish colorsMust be able to perform activities with repetitive motionsAbility to lift 25 lbs routinely/often/occasionallyAbility to crouch, bend, twist and reachAbility to push/pull 25 lbs routinely/often occasionallyAbility to work in variable temperatures high to freezingInside working conditions -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 -This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. - Employees holding this position will be required to perform any other job-related duties as requested by Management.

Keywords: WuXi AppTec Inc, St. Paul , Associate Quality Assurance Specialist, Other , Saint Paul, Minnesota

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