Company: Integrated Resources, Inc
Location: Morris Plains
Posted on: May 3, 2021
**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.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
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
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
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
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
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
Thorough knowledge of SOPs and Federal Regulations to include GLP
Familiarity with regulatory guidance documents from FDA, EMEA and
Ability to operate independently where appropriate, yet escalate
issues as appropriate, establish effective cross functional working
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
Must have strong verbal, technical writing and presentation
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY
TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES
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
PHYSICAL REQUIREMENTS AND WORKING CONDITIONS
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.
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
Information Technology; Clinical and Commercial Manufacturing;
Quality Assurance; Validation; Regulatory Affairs; and Research and
Keywords: Integrated Resources, Inc, Newark , Scientist, Other , Morris Plains, New Jersey
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