Quality Assurance Analyst – Quality Gates

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Almac Group is currently seeking a QA Analyst for our Lansdale, PA location. The QA Analyst is responsible for ensuring/confirming that all corporate products and client systems are built, maintained, and supported in compliance with established software development life cycle (SDLC) methodologies and Almac clinical technologies (act) processes and procedures.
Responsibilities include but are not limited to:
  • Certify and approve project go-live to production
    • Create initial system Validation Plans and populate Quality Gate Deliverables
    • Conduct Quality Gate reviews of SDLC deliverables, including IVRS, internal systems
    • Participate in project status and requirements meetings, when required
    • Assist in issue resolution and meeting Quality Gate and system certification timelines
  • Conduct live system maintenance build reviews
    • Complete Sub-build Quality Gates (priority is critical - top 5 clients and studies for upcoming audits)
    • Identify and report trends to Group Leader
  • Conduct live system periodic reviews
    • Complete periodic review within assigned timeframe
    • Assignment may include initial assessment in addition to full periodic review 
    • Identify and report trends to Group Leader 
  • Resource Management:
    • Manage and prioritize workload; escalate conflicting schedules to management
    • Facilitate the timely delivery of all client (internal and external) deliverables
    • Perform other work related responsibilities as assigned by management
  • Other Responsibilities:
    • Assist management in reviewing and approving ACT Standard Operation Procedures (SOPs) and Working Instructions (WIs)
    • Perform staff training on Quality related topics
    • Provide GCP, FDA, ICH, general regulatory, and internal procedure guidance to the organization
Required Experience / Education:  
  • A Bachelor’s degree in Science or related field OR Associates degree at least two years previous experience within a Pharmaceutical environment and/or Quality Role
Preferred Experience / Education:
  • IVRS systems; Software development principles, concepts and methods (eg. Computer System Validation (CSV), Agile, WaterFall)
  • 21 CFR Part 11 (EU Annex 11), HIPAA, Safe Harbor, General Principles of Software Validation, and other FDA/EU regulatory requirements and guidance documents
  • Experience working in a related Quality role: auditing or CAPA management
  • Understanding of basic quality principles
  • Familiarity with the clinical trial process and related industries
  • Knowledge of IRT development and support tools (proprietary or public domain)
  • ASQ Certification
What Almac Group can offer YOU!
  • Full medical, vision & dental benefits the 1st of the month after start date
  • 20 days of PTO to start plus 12 holidays per year
  • Company paid long and short term disability along with life insurance
  • 401k company match
  • Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing almost 7,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all.  Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process.  Please email us at [email protected] to request assistance.