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GMP Operational Quality Specialist at JMD Technologies Inc. GMP Operational Quality Specialist at JMD Technologies Inc. in Everett, Massachusetts Posted in 1 day ago.

Type:

full-time

Title:

GMP Operational Quality Sr.

Specialist Location:

Boston, MA - Fan Pier (Onsite)

Employment Type:

Contract Status:

Accepting Candidates About the Role We are seeking a GMP Operational Quality Sr Specialist to provide QA support for manufacturing operations, analytical laboratory operations, and materials management. This position is primarily focused on executed batch record review and product disposition and is largely office-based. The role requires a strong QA background with hands-on batch record review experience and GMP manufacturing environment experience. Key Responsibilities Batch Record Review & Product Disposition Review executed batch records and provide approval for quality tasks Perform final review of executed batch and critical systems documentation Determine acceptability using standard operating procedures Ensure all required documentation is present and acceptable prior to product/system release Support day-to-day batch release activities Perform activities associated with product disposition, including batch document review and source data review GMP Quality Support Review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and quality systems documentation Support manufacturing activities for cGMP compliance Provide guidance on manufacturing quality issues Support shop floor checks and audit trail review Gown into cleanrooms and controlled environments Investigations & CAPA Support root-cause analysis and product impact assessments for deviations, OOS, and OOT investigations Ensure appropriate CAPA actions are identified Collaborate with business partners to resolve quality issues and ensure compliant solutions Quality Systems & Compliance Assist with quality audits and external inspections Maintain quality documentation and files Support monthly/quarterly Quality System metrics and reporting Escalate critical and major findings to Quality management Monitor key performance indicators Author SOPs supporting commercial quality functions Continuous Improvement & Collaboration Represent Quality on cross-functional working teams Support continuous improvement projects Train employees and provide education on processes and procedures Identify and support continuous improvement opportunities Qualifications Bachelor's degree in a scientific or allied health field, or equivalent combination of education and experience Strong QA background Hands-on batch record review experience GMP pharmaceutical manufacturing environment experience Experience providing QA support and oversight of GMP manufacturing operations Good understanding of cGMPs in a pharmaceutical setting Experience with electronic document management systems such as: QDoccs Trackwise Veeva Strong communication and collaboration skills Ability to evaluate quality matters and solve problems using technical experience and sound judgment Preferred Qualifications Experience leading event investigations Strong Root Cause Analysis (RCA) experience Strong CAPA experience Experience with product disposition and batch release Experience supporting quality audits and regulatory inspections Experience with quality metrics and reporting Experience working cross-functionally in a GMP environment Experience authoring SOPs Compensation $65/hr W2 Boston, MA - Fan Pier 100% Onsite Monday-Friday, 1st Shift 12+ Month Contract