Quality Assurance Associate

4 weeks ago
Requisition ID
2017-2635
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full-time Quality Assurance Associate.The Quality Assurance Associate at Cook Myosite Inc. performs detailed quality reviews of batch records and associated records for final dispositioning and ensuring compliance with procedural and regulatory requirements.

Responsibilities

• Performs quality inspection and documentation for incoming biopsies
• Reviews and approves records and associated data in support of cGMP operation activities
• Creates batch records, product labels and performs label verification processes
• Performs quality reviews and approvals of batch records.  Responsible for dispositioning batches
• Participates in company projects as a quality representative
• Participates in risk assessment activities
• Performs investigation report writing, reviewing and closing investigation reports

• Conducts and documents training events
• Management of customer complaints
• Authoring quality system documents
• Performs various office-related duties; filing, scanning, and data entry 
• Promotes GLP/cGMP environment and follows procedural guidelines

Qualifications

• Bachelor’s degree in any Life Sciences or equivalent and/or at least 5 years of relevant experience in QA or equivalent experience
• Knowledge of cGMP regulations and good documentation practices preferred
• Demonstrates excellent problem solving and critical thinking skills

• Detailed oriented and good written and oral communication skills
• Experience in risk assessment preferred
• Must be familiar with Microsoft Office applications

 

Physical Requirements:

• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Ability to conduct and hear ordinary conversation and telephone communication
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Visual and manual acuity for working with computers and equipment

• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints

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