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Quality Control Supervisor (HPLC, Raw Materials, Finished Products & Empower)

Macpower Digital Assets Edge LLC

Danbury, CT

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Budget Management, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Relations, Data Quality, Detail Oriented, Environmental Regulations, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Government Standards, High Performance Liquid Chromatography (HPLC), ISO 9001, Instrumentation, Interpersonal Skills, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Organizational Skills, People Management, Policy Development, Problem Solving Skills, Procedure Development, Process Validation, Project Schedule, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Safety/Work Safety, Standard Operating Procedures (SOP), Team Player, Technical Presentation, Test Plan/Schedule, Testing, Time Management
LOCATION
Danbury, CT
POSTED
30+ days ago
Job Summary : Develops, implements, and maintains the activities of quality control systems. Oversees methods and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Contributes information to help develop budgets. Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations. We are looking for candidates that have worked in Pharmaceutical in Quality Control and have supervisory experience. We use Empower software for raw materials and finished products. Essential Duties: Provide general or direct supervision to exempt employees and/or skilled nonexempt employees. Act as advisor to unit or sub-units, becomes actively involved as required to meet schedules or resolve problems. Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation, and execution of the tests. Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities. Exercise judgment within defined procedures and policies to determine appropriate action. Critically review data for anomalies or trends and approve data. Lead and approve investigations of suspect or out of specification results. Ensures implementation of CAPA. May perform bench analysis, as needed. Frequently interacts with subordinates, outside customers, and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc. Contributes to cross functional projects with significant impact to company. Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Minimum Qualifications: BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training Proficiency in MS Word, Excel, and PowerPoint Strong interpersonal and organizational skills Supervisory experience. HPLC. Raw Materials. Finished Products. Empower. As a member of the Quality organization, the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player. (Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.

About the Company

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Macpower Digital Assets Edge LLC

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