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

Macpower Digital Assets Edge Private Limited

Danbury, CT

$80,000–$100,000 Per Year
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Job Description

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.

Numbers & Facts

Location	Danbury, CT
Salary	$80,000–$100,000 Per Year

Skills

Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Budget Managementunmatched
Control Systemsunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Relationsunmatched
Data Qualityunmatched
Detail Orientedunmatched
Environmental Regulationsunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
Government Standardsunmatched
High Performance Liquid Chromatography (HPLC)unmatched
ISO 9001unmatched
Instrumentationunmatched
Interpersonal Skillsunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Organizational Skillsunmatched
People Managementunmatched
Policy Developmentunmatched
Problem Solving Skillsunmatched
Procedure Developmentunmatched
Process Validationunmatched
Project Scheduleunmatched
Quality Controlunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
Technical Presentationunmatched
Testingunmatched
Time Managementunmatched

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