Pharmaceutical Development/Technical Operations Sr. QAV Specialist - Bedford, MA Bedford, Massachusetts

Orbis Clinical is seeking a Sr. QAV Specialist located in Bedford, MA for 6 months.

Job Title: Sr. QAV Specialist

Location: Bedford, MA

Contract: 6 months

Summary

The Senior Quality Assurance Validation Contractor position is for a 6-month onsite contract position at the company facility located in Bedford, MA to provide support primarily for AM805 project related work.

Responsibilities

Provide onsite QAV support at company facility located in Bedford, MA to support the following QAV activities for the AM805 tech transfer project:

• Review and approval of equipment, automation, facility, and utility system validation lifecycle documents for the AM805 tech transfer project including but not limited to:
  • SLRA (System Level Risk Assessments)
  • DI (Data Integrity) Assessments
  • DR/DQ
  • Specifications
  • IQ/OQ/PQ Qualification Protocols
  • Validation Issues
  • IQ/OQ/PQ Qualification Reports
  • Risk assessments
• Review and approval of BMRAM work orders for equipment, automation, facilities, and utilities.
• Independently represent QAV in cross functional project meetings.

Requirements

• A B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
• Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles.
• Direct experience with facility, equipment, and utility validation is required. Experience with cell culture and single use systems is preferred.
• Knowledge of relevant FDA and EMA regulations.
• Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution documentation reviews and communication of quality requirements aligned with program procedures in cross functional meetings.
• Excellent oral and written communication skills with strong technical writing experience is required.
• Excellent organizational skills and attention to detail.
• Experience with continuous improvement efforts.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $89.65 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.