Quality Control Specialist

KEY RESPONSIBILITIES Design, develop, maintain, and initiate continuous improvement activities for the material specifications preparation/revisions and execution until it is processed for approval. Author and reviewer for test method review, risk assessments, change controls, SOPS, specifications, etc. Complete activities in compliance to applicable SOPs, specifications, and compendia requirements in an efficient and high quality manner. Evaluate compendia monographs, plan for and order reagents, supplies, instrumentation requirements Work closely with others in a team environment within the Quality Control Laboratory and act as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development. Coordinates and participates in material review meetings and/or batch readiness meetings. Maintain schedule routine maintenance of laboratory instruments for follow up repairs and/or tracking the calibration activities for timely completion Working closely with validations team to complete the required tasks for Instrument qualifications process Required assistance on record keeping for Laboratory personnel training matrix updates periodically Purchasing of laboratory reagents and consumables. Perform testing, analysis and data reporting for test samples as needed. Inform budgetary decisions for material testing costs. Ensure maintenance and calibration of analytical instruments in compliance with SOPS and GMP regulations. Develop the Materials testing Training program for QC analysts and lead the training activities. Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other project or material specific documentation with particular attention to accurate record keeping. Perform all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment. Perform additional duties as assigned by laboratory management Qualifications Education Requirements: Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field WORK Experience: 5+ years of experience in a pharmaceutical laboratory or regulated environment Hands-on experience performing quality control work within a laboratory and operating analytical testing equipment Experience working with potent, cytotoxic materials and parenteral drug products preferred Functional OR TECHNICAL Skills: Knowledgeable in general analytical techniques Knowledgeable in analytical testing equipment and related procedures. Knowledge of USP, FDA, and ICH requirements and procedures, EU/EP and PMDA experience a plus High proficiency operating analytical testing equipment and troubleshooting Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical. Highly motivated, self-directed, detail oriented, quality minded with strong organizational skills. Operates with a sense of urgency in a fast-paced environment Ability to comprehend and follow standard operating procedures and test methods. Proficient in Microsoft Office Applications (Word, Excel, PowerPoint etc.), with ability to learn and master new computer applications. Strong technical writing skills Able to exercise independent intellectual judgment using data driven decision making Excellent oral and written communication skills

Salary : $47,000 - $69,000