Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $32.40 – $34.40/hr.
Summary:
The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic, results-oriented, and experienced Quality Assurance Specialist to join our organization as a Remote Worker. The candidate will be responsible for supporting the global Manufacturing Execution System (MES) projects and initiatives to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment. This is an excellent opportunity for a highly experienced and talented individual to contribute to Company’s mission of serving patients.
Key Responsibilities:
- Ensure quality oversight and compliance for MES and PT project activities.
- Support validation and qualification efforts for computerized systems in alignment with GMP requirements.
- Review and approve documentation related to MES workflows, change controls, and deviations.
- Collaborate with cross-functional teams to ensure quality standards are met during system implementation.
- Participate in risk assessments and support mitigation strategies for quality-related issues.
- Ensure that quality processes and procedures are updated and aligned with project deliverables.
- Provide training and guidance on quality practices and regulatory compliance.
- Support audits and inspections by providing documentation and subject matter expertise.
- Monitor and report on quality metrics and continuous improvement initiatives.
- Ensure alignment with global quality standards and local regulatory requirements.
Basic Qualifications:
- Bachelor's or Master’s degree in Life Sciences, Engineering, or related field.
- Proven experience in quality assurance within a GMP-regulated manufacturing environment.
- Experience supporting MES and process transformation initiatives.
- Strong understanding of validation principles and regulatory compliance.
- Excellent documentation and communication skills.
- Ability to work collaboratively in cross-functional teams.
- Detail-oriented with strong analytical and problem-solving skills.
- At least 5 years of experience in quality assurance or related roles.
Top 3 Must Have Skill Sets:
- Hands on with PASX along with associated integrations to Level 2 and Level 4 systems.
- Experience in designing, deploying, and maintaining Körber’s PASX MES system.
- Pharma / GxP regulated environment experience.
Pay Transparency: The typical base pay for this role across the U.S. is: $32.40 – $34.40/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.
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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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