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Company: Integrated Resources, Inc
Location: Morris Plains
Posted on: May 3, 2021

Job Description:

**Replacement for: M. Miranda**
*Candidate must be local to Morris Plains NJ

This Quality Control Scientist, Analytical Data Reviewer is a subject matter expert on review of documentation associated with the operation of a cGMP QC laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within Product.
Reviews cGMP data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis and wet chemistry methods. Ensures that standards for documentation and comply with SOPs (analytical methods and Good Documentation Practices) and industry standards.
Strong technical knowledge including an understanding of laboratory procedures, methodology and standards. A minimum of three years of QC analytical laboratory experience is preferred.
Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines. Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
Compile and summarize analytical raw data in various physical and electronic report formats.
Reviews protocols, analytical reports and certificates of analysis.
Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
May coordinate and track progress of analytical testing internally or at CROs.
May participate in regulatory agency audits and inspections

It is each employees responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employees responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.
Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
Ability to operate independently where appropriate, yet escalate issues as appropriate, establish effective cross functional working relationships.
Strong attention to detail is essential. Well-developed organizational, interpersonal communications, writing, and strong listening skills are required.
Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
Must be able to recognize the impact beyond a single site, project or collaboration.
Must have strong verbal, technical writing and presentation skills.
M.S. degree in Biochemistry, Molecular Biology or a related field, and three (3) years relevant experience or B.S. degree and five (5) years of relevant GMP lab experience with biotherapeutics. Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
Three to five years of experience testing pharmaceutical products in a GMP-regulated QC laboratory. Experience with HPLC / UPLC, spectrophotometers, and capillary electrophoresis is preferred.
Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, raw material analysis, method validation guidelines, analytical method transfers, finished products, and stability testing.
Environment: Work is performed in a GMP lab setting with exposure to a variety of chemicals. Exposure to intermediates and final drug products. Repetitive motions are involved.
Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects. Involves sitting most of the time, but may include walking or standing for brief periods of time.
Equipment Used:
Office Equipment
Laboratory and/or Related Equipment (e.g., instrumentation, fume hoods, incubators, freezers, calibrators)

Vision: May need to pass 20/20 near focus visual acuity test (with or without correction) and be able to read font size 3 vial labels and or color blindness testing. Otherwise, needs to see in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
Hearing: Hear in the normal audio range with or without correction.
Information Technology; Clinical and Commercial Manufacturing; Quality Assurance; Validation; Regulatory Affairs; and Research and Development

Keywords: Integrated Resources, Inc, Newark , Scientist, Other , Morris Plains, New Jersey

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