Quality Systems Coordinator

CLENE NANOMEDICINE INC • North East, MD

7d • $65,000 - $72,000

About The Position

Summary:
The Quality Systems Coordinator provides quality oversight; supports all departments including, but not limited to, Manufacturing, Q/C PChem, Bioanalytical, and R&D, for the manufacturing and testing of non-clinical, clinical, and commercial products; provides support in driving quality initiatives, maintaining/improving quality infrastructure and participates, as needed, on various CMC and GxP-related project teams.

The Quality Systems Coordinator is accountable for assuring compliance with the quality systems, quality oversight at the project level, generated metrics to drive continuous improvement, and assuring the quality of materials manufactured and data generated in support of clinical trial material and commercial products.

Requirements

• Bachelor’s degree in biological sciences, chemistry, or a related field required. Equivalent professional experience may be considered in lieu of a degree.
• Minimum of 6 years of experience in the pharmaceutical or biotech industry, preferably within a GxP environment supporting the manufacture of clinical and/or commercial products.
• Working knowledge of cGMP principles concerning appropriate regulatory requirements (FDA, ICH guidelines, etc.)
• Demonstrated ability to communicate clearly and professionally, both written and verbal.
• Ability to independently analyze and resolve moderately complex to complex issues.
• Proficiency in applying QA principles, concepts, industry practices, and standards.
• Excellent documentation skills and attention to detail
• Working knowledge of MS Office Suite (Word, PowerPoint, Excel).
• Demonstrates a consistently professional demeanor and a strong work ethic.
• Exercises a high level of discretion in all matters involving confidential data.
• Experience in writing, reviewing, and approving Quality System documents, including change controls, deviations, out-of-specification (OOS) investigations, and CAPA reports.
• Demonstrated knowledge of the drug development lifecycle, including support of products through Phases I, II, III, and IV.
• Experience identifying technical manufacturing problems and recommending effective resolutions.
• Exceptional documentation and organizational skills, with the ability to prioritize and manage multiple tasks efficiently.

Responsibilities

• Writes, reviews, and approves GMP/GLP/GCP (GxP) documentation (i.e., SOPs, protocols, reports).
• Provides Q/A oversight support over GxP activities.
• Monitors quality systems, such as deviations, investigations (OOSs), corrective and preventive actions (CAPAs) for timely processing and closure.
• Develops and utilizes tools to perform risk assessments.
• Tracks Quality Management System (QMS) and Annual Product Review reports for review.
• Supports equipment, utility, and facility qualification activities, including equipment calibration and maintenance programs.
• Performs quality review of test method validation, cleaning verification/validation, stability studies, and process validation documents.
• Supports regulatory submissions.
• Aids in process improvements with respect to quality, including change control, deviations, OOSs, and CAPAs.
• Supports audits (internal/external & third-party assessments, regulatory inspections).
• Other duties as assigned.

Benefits

• Up to 4 weeks paid vacation.
• Paid holidays.
• Eligible for medical, dental, vision, and prescription coverage (employee & family).
• 401(k) retirement plan with employer match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees