Quality Control Systems Manager (771030)

Coordinate and implement the quality assurance program to facilitate efficient production operations (25%). Review quality control policies, procedures, and standard operating procedures (SOPs) for the manufacturing and quality assurance processes, to ensure alignment with company policies and industry standards (10%). Oversee the performance of quality control systems to ensure effectiveness, identify areas for improvement, and implement corrective actions (10%). Review Part 11/ERES System Specific Compliance assessments and prepare formal reports (10%). Implement quality control and assurance procedures, training, and oversight to ensure the integrity of data generated to support testing processes (10%). Collect and analyze product samples throughout the manufacturing process to ensure they meet established quality standards, conduct root cause analysis, and recommend process adjustments to maintain compliance with company and regulatory guidelines (10%). Identify compliance and data integrity issues related to quality control equipment and implement effective resolutions (10%). Perform vendor onboarding for new system installations and system software upgrade process (5%). Coordinate with end users and process owners to develop quality guidelines, testing procedures, and strategies to eliminate defects (5%). Prepare for internal and external audits and inspections, ensuring readiness and addressing quality-related findings (5%). May be relocated to unanticipated sites around US.

2 years of experience as a Quality Assurance Engineer, Validation Engineer, or related. Must have 2 years of experience (simultaneous and concurrent with the experience required above) with drafting and reviewing quality assurance or validation SOPs and protocols for use in pharmaceutical development; implementing cGMP practices; and providing support for SQ/IQ/OQ/PQ (Software, Installation, Operation, and Performance qualification) protocols.

Master’s degree in Pharmacy, Chemistry, or related/equivalent

Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #771030 in the subject line.

Thank you.