Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $40.00 – $43.00/hr.
Summary:
This position supports Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
Responsibilities:
- Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures.
- Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
- Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues.
- Executes quality oversight directly in Quality systems.
Qualifications:
- Bachelor’s degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
- 1+ YOE in Commissioning, Qualification, and Validation experience.
- Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices.
- Experience managing projects through completion while meeting timelines.
- Evaluating documentation and operations according to company procedures and related regulations.
- Experience working with Quality Systems.
- Strong organizational skills and ability to manage multiple tasks at one time.
- Effective communication skills (both written and verbal).
- Demonstrated ability to work as both a team player and independently.
- Solid understanding and application of aseptic behaviors and principles
Top 3 Must Have Skill Sets:
- Commissioning, Qualification, and Validation experience
- Experience with direct use of GMP quality systems (i.e. Deviation and Change Management, Equipment Maintenance and Lifecycle Management, Controlled Document Management systems)
- Direct experience working or supporting GMP manufacturing, Facility and Engineering, or Quality Assurance teams within the biotech industry
Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 – $43.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
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