Quality Assurance - Governance Analyst
Job Posting for Quality Assurance - Governance Analyst at Almac Group
Almac Group is currently seeking a QA Governance Analyst for our Lansdale, PA location. The QA Governance Analyst supports the QA organization within Almac clinical technologies. This position provides support to the risk and vendor management portions for Almac Clinical Technologies.
Responsibilities include but are not limited to:
- Work with the client and cross functional Almac teams to assess risks for projects; this may include:
- Interview Subject Matter Experts (SMEs) and involved employee(s) to assist in identifying project risks
- Schedule meetings with required team member(s)
- Review risks against documented process per SOP, WI.
- Utilize problem solving techniques to determine root cause and other appropriate factors
- Act as direct client liaison to client as it relates to risk and any follow-up questions
- Identify and analyze trends arising from individual investigations
- Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms
- Act as direct client liaison as it relates to specific investigations during client calls and audits
- Report the performance of the quality system as a basis for improvement of the quality system
- Maintain and update a Risk Repository database with key performance indicators
- Update the risk repository as needed
- Identify areas of improvement surrounding the identification of risk
- Review Vendor performance standards and lead efforts in evaluations/audits of current and prospective vendors. This includes, but it not limited to:
- Creating and reviewing RFIs
- Creating and maintaining Vendor KPIs
- Assessment of Vendor Risks
- Organizing and Conducting Vendor evaluations/audits
- Provide Regulatory Support for both internal and external inspections.
- Manage primary support for both Almac and Client Regulatory inspections
- Facilitate responses to any regulatory based inquiries
Qualifications:
Required Experience / Education:
- High school with a minimum of four (4) years of required experience OR Associate's degree with a minimum of two (2) years of required experience OR Bachelor's degree in Science, Organizational Management, Business, Computers, or related field
- Level I: Basic knowledge of QA and Regulations, gained in either an educational setting, in a professional environment or through an internship
- One year working experience
- Level II: Demonstrated familiarity with Basic Quality and Regulations
- Demonstrated familiarity with Basic Quality and Regulations
- 2 years working experience OR one year experience with Basic Quality and Regulations
- Level III:
- 4 years’ experience reviewing regulated systems and using Good Documentation practices within a Pharmaceutical environment
- 4 years’ experience working in a software/ Computer System Validation (CSV) environment
- 2 years performing investigation activities
- Level IV: Recognized expert/SME
- 6 years’ experience reviewing regulated systems and using Good Documentation practices within a Pharmaceutical environment
- 6 years’ experience working in a software/ Computer System Validation (CSV) environment
- 4 years performing investigation activities
Preferred Experience / Education:
- Bachelor’s degree in Science, Organizational Management, Business, Computers, or related field
- IVRS systems; Software development principles, concepts and methods (e.g. 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, Risk, or Vendor 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)
- Microsoft Access or SharePoint experience
What can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Hybrid work available for applicable roles
- 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 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.
EEO is the Law
EEO is the Law GINA Supplement
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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