Position Title: Quality Assurance Specialist – Global MES & GxP Compliance
Work Location: Remote Worker - Strong presence for EST
Assignment Duration: 12 months (Possible Extension)
Work Arrangement: Remote
 
Position Summary:
The Quality Assurance Specialist will support global MES projects to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment.
 
Background & Context:

• 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.
• This is an excellent opportunity for a highly experienced and talented individual to contribute to our organization’s mission of serving patients.

 
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.
• At least 5 years of experience in quality assurance or related roles.
• 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.
• 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.

 
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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/hr.