• Job Description

  Req#: 32396613170

  5440- Quality Validation Specialist / Senior Quality Specialist

  5 days ago Be among the first 25 applicants

  Description

  Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

  Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

  Company Culture Guidelines & Values

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

  Quality Validation Specialist Responsibilities

  Responsible for quality oversight of validation activities at the Takeda Los Angeles facility. This person will have quality signatory responsibility for approval of qualification, validation, and final report documents. Ensure that the validation and compliance requirements are met according to guidelines and Takeda standard operating procedures. Proficient in facility quality systems and participates as subject matter expert of validation requirements. The scope includes validation for Facility, Equipment, Critical Utility, Automation Systems, Cleaning and Process.

  Essential Duties And Responsibilities

  • Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines.
  • Provide validation expertise and support for the development or modification phases of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
  • Review from a quality perspective, the validation approach and documentation as required to assure compliance with procedures and regulatory submissions.
  • Participate in the risk assessment related to the project.
  • Evaluate, analyze, and approve protocol discrepancies and ensure that the required corrective actions are taken.
  • May perform other duties as assigned.

  Requirements

  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must have experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
  • Typically requires BA or BS degree preferably in the engineering or science field. 5+ years of related experience.
  • Must be able to lift, push, pull and carry up to 25 lbs.
  • Must be able to work in controlled environments requiring special gowning.
  • Must be able to work multiple shifts, including weekends.

  For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.

  • Verista is an equal opportunity employer.

  National (US) Range: $70,491—$142,808 USD

  Benefits

  Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture.
  • Competitive pay plus performance-based incentive programs.
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances.
  • 401(k) Retirement Plan (Employer Matching benefit).
  • Paid Time Off (Rollover Option) and Holidays.
  • Tuition Reimbursement.
  • Team Social Activities (We have fun!).

  For more information about our company, please visit us at Verista.com

  Seniority level

  Mid-Senior level

  Employment type

  Full-time

  Job function

  Quality Assurance

  Industries

  Pharmaceutical Manufacturing

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• About the company

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