JUNIOR Process Validation

1 week ago

Fremont, California, United States ApTask Full time
About Client:
The client is a prominent pharmaceutical company with a rich history and global presence. It operates worldwide, conducting research, developing, and manufacturing a wide range of innovative medications and therapies. The company focuses on several therapeutic areas, including respiratory diseases, cardiovascular diseases, metabolic disorders, oncology, immunology, and diseases of the central nervous system. It is recognized for its commitment to research and development, investing significantly in discovering novel treatments and advancing medical science.
With a workforce comprising diverse and skilled professionals, it remains committed to its mission of improving lives and driving medical advancements. Through its dedication to innovation, research, and healthcare solutions, the company continues to shape the future of medicine on a global scale.

Rate Range:

Job Description:
Candidate will work with MSAT Process Validation group with the following responsibilities:
  • Responsible for performing data mapping of Continued Process Verification (CPV) software.
  • Assist in the development and implementation of CPV data mapping strategies.
  • Collect, organize, and map process data and QC data from various sources to ensure accurate and comprehensive data sets.
  • Perform CPV evaluation and generate CPV reports.
  • Generate new work instruction and curriculum to implement new CPV software.
  • Maintain accurate and up-to-date documentation of CPV activities and data mappings.
  • Support other process validation projects (as needed) to ensure processes are validated to required standards.
  • Reviews and interprets data for accuracy for completed validations/re-validations and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
  • Manage all moderate troubleshooting efforts for protocol discrepancies.
Requirements:
  • Basic understanding of GMP (Good Manufacturing Practices) and regulatory guidelines.
  • Proficiency in Microsoft Office including Word, Excel, and Visio.
  • Experience with Minitab or similar statistic analysis software is preferred
  • Process validation background is preferred.
  • Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes is preferred.
  • Excellent technical writing and verbal communication skills
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a team environment.
  • Demonstrate ability to manage multiple activities while maintaining a high level of organization.
  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.

About ApTask:
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com

Applicant Consent:
By submitting your application, you agree to ApTask's (www.aptask.com) Terms of Use and Privacy Policy, and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at 732-355-8000 or help@aptask.com. Message frequency may vary. Msg & data rates may apply.

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