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Senior Manager Quality Control - Chemistry & Pharma

Excellent Opportunity with our direct pharmaceutical client based in Baltimore, MD - Maryland

Job Summary:
Manages team of QC Analyst, QC Chemists and QC Microbiologists.
Recommends decisions/course of actions in atypical situations.
Manages department operating and capital budgets consistent with QC business needs.

Responsibilities and Duties:
Manages the activities of the in-house QC laboratory and contract laboratories with respect to the testing of API, raw materials, WIPs and final product.
Ensures all laboratory work is conducted in compliance with applicable safety and environmental regulations.
Manages the activities of the in-house Microbiology laboratory with respect to the Environmental Monitoring (EM) program for the Baltimore site.
Manages personnel in the QC and Microbiology functions.
Performs annual and as-needed personnel performance evaluations.
Manage Direct Reports over diverse areas; Outline, Monitor and Provide Feedback on Performance.
Prepares (and as appropriate also reviews) laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation, and laboratory notebooks in accordance with cGMP, or SOPs, as appropriate.
Ensures the integrity of QC data. Ensures all laboratory work is conducted in compliance with applicable safety and environmental regulations.
Develops, implements, and maintains appropriate systems and procedures required by the CGMPs for the laboratories.

B.S./B.A. in Chemistry, Pharmacy or Pharmaceutical Sciences required; Masters preferred

8+ years of experience in the Pharmaceutical Industry in Quality Control with demonstrated knowledge and leadership in pharmaceutical analysis.
Proficiency in the areas of HPLC, GC, UV, IR , and pharmaceutical analysis.
In depth knowledge of cGMPs, USP/EP/JP Testing, and FDA/EMA/PMDA Guidelines.
Substantial experience with Root Cause Development .
Prior supervisory experience required.
Deep understanding of Data Integrity Guidelines, requirements and best practices for EU and US.
Demonstrated history of successful interactions with regulatory inspectors.
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