Compliance Specialist III

  • location: Swiftwater, PA
  • type: Contract
  • salary: $23.68 - $27.87 per hour
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job description

Compliance Specialist III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

location: Swiftwater, Pennsylvania
job type: Contract
salary: $23.68 - 27.87 per hour
work hours: 9 to 5
education: Bachelors
The Centers of excellence (CoE) develop execution plans to drive harmonization, efficiency and continuous improvement of business and operational practices. The CoEs lead collaborative network of experts and provide practical and sustainable solutions by assessing the current landscape of each manufacturing site and system, current and upcoming health authority regulations and industry trends and best practices.

Within the COE platform, the Validation CoE has defined key priorities and we are looking for a validation expert manager to assist the validation CoE head to execute the roadmap for those priorities on Continued Process Verification (Validation phase 3 / CPV), Process Criticality Assessment (Quality by Desin principle / evaluation of CQA, CPP, CMA), Risk based Validation Strategies fro PPQ (Validation stage 2b) and global quality documents reviews.

Under the directives of the Validation CoE Head and CoE platform Head, the Quality validation expert manager will:

Organize and facilitate the priority task force meetings, perform manufacturing sites evaluation and assessments, Identify remediations with the sites, follow up on action and ensure deliverables are met on time, alert in case of roadblock or delays, provide input in validation document reviews, assist in organizing monthly review meeting with the Validation CoE members.

The Quality Validation Expert manager will work with multiple sites (11) globally (Argentina, Mexico, US, Canada, France, India, China, Thailand), Critical thinking and ability to challenge ways of working are key in the context of the Center of excellence.

The candidate is expected to work well under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

Key competencies

- Process validation Lifecycle (biologics / vaccines)

- Knowledge of Health Authorities environment: Europe, US, Canada, Japan, China, Brazil, Mexico, OMS, ...

- Quality by Design, Control Strategy

- Quality risk management, FMEA

- Project management and Communication

- Continuous Quality Improvement and Quality Culture

Key deliverables

- CoE Priorities defined in the CoE roadmap completed on time

- Site assessment and remediation plan

- Global documentation reviews

  • Engineer/master degree, with 8-10+ years in validation.
  • Risk-based approach / ICHQ9 mindset
  • Vaccines & Biotech Processes understanding/knowledge
  • Methodology ability
  • High level of autonomy
  • Excellent communication skills, able to manage cross functional communications
  • Leadership during workshops / Experience in understanding customer's voice and quality requirements is a must
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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