Specialist Quality Assurance (EST Preffered)

Position Title: Quality Assurance Specialist
Work Location: Remote (Candidates in EST zone preferred)
Assignment Duration: 8 months (possible extension)
Work Arrangement: Remote
Position 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. 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 our organization s mission of serving patients.
Background & Context: Ideal Candidate: B.S. 4-5 YOE. Prior pharma, GMP knowledge, and minimum 1-2 YOE working with the MES platform.
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.
Qualification & Experience:
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.
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
Hands-on with PASX along with associated integrations to Level 2 and Level 4 systems.
Experience in designing, deploying, and maintaining Krber s PASX MES system.
Pharma / GxP regulated-environment experience.