Quality Validation

3 weeks ago

Andover, United States Actalent Full time
Job DescriptionJob Description

Great opportunity to get your foot in the door with one of the top Biopharmaceutical companies in the Andover, MA area

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

Description:

  • Provide quality oversight for transfer of analytical methods
  • Provide quality oversight for method verification/qualification/validation protocol, exception, and report reviews
  • Adhere to regulatory guidance, policies, and procedures for qualification and validation of analytical methods
  • Independently coordinate and directly interface with multiple departments both internally and with ourcontract manufacturing and testing organizations
  • Use risk management principles for qualification and remediation efforts
  • Provide regular updates directly to Management
  • Perform other related duties as assigned

Education and Skills Requirements:

  • 8-12 years of relevant experience and bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
  • Direct experience in analytical method qualification and validation using FDA, USP and ICH guidance required.
  • Experience with method development, qualification and/or validation for clinical and commercial in-process and release testing required
  • Must have in-depth understanding and application of GMP and validation principles, concepts, practicesand standards in the US and internationally
  • Knowledge of biologics/gene therapy processes desirable
  • Able to execute complex concepts, techniques, and standards and new applications based on qualityprinciples and theories
  • Able to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
  • Demonstrates knowledge of industry best practices and trends
  • Excellent verbal, written, and interpersonal communication skills are required

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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