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Job Details

Summary:

Reporting to the Manager of Quality Assurance, the QA Associate – Quality Operations provides guidance and direction to daily Quality and Production activities to maintain compliance with corporate and regulatory requirements.  

Primary Duties and Responsibilities:

• Provides direction and guidance to daily QA and Production activities

• Audits production batch records throughout the packaging process for accuracy and compliance

• Conducts final audit prior to submitting to Product Release

• Performs serialization activities, including but not limited to sending print, releasing, suspending, and cloning a work order to support production needs

• Verifies and corrects non-controlled product and packaging component discrepancies within the applicable systems

• Ensures applicable deviations and supporting documentation is provided in the batch record

• Performs Quality in-process checks as needed

• Performs Specific Gravity testing and TOC analysis

• Performs Cleaning Validation swabbing upon the request of the Stability department

• Creates, Reviews and Updates WIs and SOPs applicable to daily activities

• Escalates non-conformance issues during the production process to management and leads the root cause analysis of quality incidents, participates in investigation discussions, and drafts

• Unplanned Deviations prior to submitting it for management review

• Actively engages in all technical training, as well as compliance and other training required as a member of the quality team

• Works in partnership with supporting areas (Sampling, Label and Documentation, Production, Warehouse) to resolve issues and improve processes by participating in continuous improvement activities to increase efficiency and team member engagement in the production area

• Participates on the site internal audit team representing QA Production. Adheres to all cGMP, safety regulations, and understands SOP's

• Performs all other duties as assigned

Required Skills and Qualifications:

• Requires completion of a high school diploma, general education degree (GED) or equivalent combination of experience and education

• Requires five or more (5+) years of equivalent work experience

• Familiar with quality assurance concepts, practices and procedures in packaging of pharmaceuticals

• Ability to read and understand the English language for the purpose of reading documents, product labels and instructions

• Must have good written skills for the purpose of accurately completing compliance documentation for production runs 

• In-depth knowledge of the function and basic problem-solving capabilities for the purpose of troubleshooting issues during production activities

• Must possess basic mathematical skills

• Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others 

• Strong organizational skills as well as detail oriented 

• Ability to use good judgement in order to carry out detailed instructions

• Ability to work independently and handle a variety of tasks simultaneously

• Good verbal and written communication skills 

• Computer literate with ERP Systems, Microsoft Office (Outlook, Word, Excel) and computer-based training

Work Environment:

• The work environment characteristics described here are representative of those a team member encounters while performing the essential functions of this job

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• The noise level in the warehouse is generally noisy

Physical and Mental Requirements:

• The physical demands described here are representative of those that must be met by team member to successfully perform the essential functions of this job

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Physical activity requiring reaching, bending, kneeli