Get Clinical Research JobsGet Clinical Research Jobs

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.
Please leave blank
Minimum of 400 (0) characters
Please leave blank
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs

Employer Information

Previous Page New Search

I love this site. It is the one site that puts ALL the Clinical Research Jobs under one roof. It makes my job searching very easy.

Denise Farris, Clinical Research Coordinator

Join 3,412 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Clinical Research Jobs in Maryland

  1. Physician / Neurology / Maryland / Permanent /...

    Baltimore, MD
    , neuromuscular, concussion, movement disorders, and general neurology) * Clinical research trials...
  2. Experienced Cardiac Surgery ICU Intensivist

    Baltimore, MD
    Division's Clinical Research Unit is actively enrolling patients in over 40 clinical research protocols...
  3. Emergency Medicine Physicians

    Baltimore, MD
    bedside teaching of residents and medical students as well as clinical research. The Baltimore VA...
  4. Clinical Research Associate

    Rockville, MD
    The Clinical Research Associate in collaboration with project teams is responsible for planning...
  5. Clinical Research Associate II

    Bethesda, MD
    Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support...
  6. Clinical Research Associate (NCI)

    Frederick, MD
    ’ (NIAID's) Intramural Clinical Research Community. The Clinical Research Associate (CRA) II...
  7. registered nurse

    Baltimore, MD
    facing/caregiving role or grow (leadership operations, corporate functions, integrated care, clinical...
  8. STAR RN

    Baltimore, MD
    (leadership operations, corporate functions, integrated care, clinical research), we can guide you on that...
  9. Academic Nephrologist

    Baltimore, MD
    candidate will also be expected to be involved in focused basic/clinical research. Successful...
  10. Endocrinology Physician...

    Baltimore, MD
    A Endocrinology Physician Endocrinologist/Metabolism practice is seeking a qualified physician for...
Browse all Clinical Research Jobs in Maryland
Previous Page New Search