Quality Associate

Quality Associate I Exempt

Summary 

Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Responsible for ensuring compliance of Sterility Assurance and Quality activities to the applicable requirements. Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality. Responsible for implementation and management of the Baxter quality system within the compound unit.

Responsibilities:

  1. Communication and Training o Support the training program, including the periodic qualifications of pharmacy employees o Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance 
  2. Document and Data Management o Own and approve local documentation, as required. o Ensures all procedures are controlled and current versions are available to staff as required 
  3. Sterility Assurance o Support the Environmental Monitoring and Sterility Assurance program for cleanrooms and ensure compliance with applicable requirements o Lead/Investigate all Sterility Assurance related exceptions i.e. Microbiological OOLs, particulate Matter OOLs, customer complaints and qualification failures etc.
  4. Quality System Measurement and Review o Management of the CAPA system using Track wise software o Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames o Ensure outcomes, decisions and actions of the review are documented o Track and trend on a monthly basis quality system data and indicators, including but not limited to Environmental Monitoring data, Quality Incidents, NCR/CAPAs and Complaints. Trending should include timeliness in completion as well as actual numbers o Management of complaints using TW8 o Reporting any adverse events to Pharmacovigilance and the Business management representative o Maintain a local change control process to ensure all changes are fully documented o Ensuring all changes are assessed for risk and impact prior to implementation o Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame 
  5. Validation o Support the management and schedule of the site Validation Master Plan o Ensuring all equipment used for the manufacture and storage of product is validated before use 
  6. GMP and Facilities and Equipment Control o Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards o Ensuring site-wide local systems are in compliance with Company Corporate and Regulatory / GMP requirements / EHS 
  7. Audit Management o Support the audit process for the facility, organization of the management team and staff to ensure a successful audit o Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue 
  8. Provide Quality Support to various Company projects and perform other Quality duties as assigned by Quality Manager. 

 

Requirements:

  • Bachelor Degree of Science and One 1 to Three 3 years in Quality Experience in GMP/SOP related industry/Pharmaceutical applications or Master Degree of Science and One 1 year in Quality Experience in GMP/SOP related industry/Pharmaceutical applications.
  • Managing Windows Word, Excel, and Power Point programs.
  • Management JDE and Outlook.
  • Fully Bilingual English and Spanish Written and Spoken
  • Strong understanding of GMP and aseptic operation/techniques
  • Strong understanding of quality systems,

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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