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Analytical Chemist, GLP/GDP Documentation Specialist – Entry Level
Ref No.: 18-29527
Location: 315 Enterprise Drive Plainsboro, New Jersey
Job Description:
Job Title: Analytical Chemist, GLP/GDP Documentation Specialist – Entry Level
Location Address: 315 Enterprise Drive, Plainsboro, New Jersey 08536
Duration: 1 year


The Analytical Chemist, GLP/GDP Documentation Specialist is responsible for supporting the Research and Development Analytical Laboratory activities (studies, routine testing and method development / validation activities, including overseeing and ensuring GLP and GDP documentation compliance and initiatives as well as other related testing and documentation activities) for Regenerative Technology projects as directed for the purpose of achieving corporate goals. For the Analytical Chemist, GLP/GDP Documentation Specialist role, analytical testing and documentation-related duties are split and vary based on laboratory priorities and/or business needs, as directed by the Sr. Manager of Analytical Services.


ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, which includes but not limited to the following:
• Perform chemical analysis of prototype materials, including but not limited to routine assays of chemical components, determination of impurities, enzymatic degradation, spectroscopy, and chromatography
• Perform physical characterization of prototype materials, including optical microscopy, scanning electron microscopy, mechanical testing, rheometry, particle sizing, and thermal analysis
• Comply with GLP, OSHA and all internal and external regulations and guidance
• Develop advanced knowledge of a focused test area
• Train new R&D lab and Quality Control laboratories personnel on new testing procedures for various biomaterials and medical devices
• Assist Sr. Manager of Analytical Services to assure operation of the Product Development Laboratories in accordance with GLP and OSHA standards
• Work as part of a team to develop and validate test methods to support the design and development of implantable Regenerative Technology products from concept phase through launch, following GLP, ICH, USP and Design Control Procedures
• Transfer new analytical methods to Quality Control laboratories in accordance with ISO and FDA standards
• Provide direct testing support to the Quality Control laboratories when they are requesting personnel resources
• Demonstrate excellent communication skills through:
o Summarizing data and communicating results to the Analytical Laboratory team
o Preparing reports and presentations
o Articulating laboratory goals and responses, communicating with management regarding laboratory priorities
o Progress reporting
o Make arrangements with facilities, safety, and support personnel, and with outside vendors for calibration, testing and other services
• Maintains excellent laboratory behavior which includes but not limited to GDP, chemical hygiene and all EHS requirements
• Demonstrate excellent analytical skills in analyzing and summarizing data to key stakeholders, maintaining databases and in supporting laboratory priorities
• Demonstrates excellent organizational skills in supporting group responses to laboratory priorities and maintaining databases
• Assists in instrument / method troubleshooting
• Assists in developing and supporting new laboratory test capabilities
• Assists in developing the laboratory work flow using GLP and regulatory principals
• Assists and participates in the design of Validation Plans
• Assists in the review and improvement test methods and various procedures in support of overall laboratory continuous improvement initiatives
• Complies with and completes all required internal and external training in a timely manner as well as maintains complete and accurate training records
• Participates in the design of laboratory and Test Development plans
• Assists in the support of internal and external audits
• Supports laboratory investigations using the appropriate tools and methodologies for all related OOS, OOT, deviations, events, etc.
• Supports any necessary remediation work related to compliance gaps, audit findings, CAPAs, etc.
• Troubleshoot technical issues encountered during physical and chemical characterization
• Provide high-level and detailed quality review (and approval, where appropriate) of various laboratory documentation (operation procedures, test methods, protocols, validations, qualifications, validation / technical service reports, etc.) that are generated as well as for those that exist, applying expertise to ensure Quality/GLP/GDP compliance, as directed by the Sr. Manager of Analytical Services
• Prepares and/or assists with composing various laboratory documentation based on laboratory priorities and/or business needs, applying expertise to ensure Quality/GLP/GDP compliance, as directed by the Sr. Manager of Analytical Services
• Leads and/or assists Sr. Manager of Analytical Services with periodic reviews of documentation as part of laboratory's overall continuous improvement initiatives, as directed by the Sr. Manager of Analytical Services
• Serves as appointed Records Retention Coordinator for documents pertaining to the Analytical Laboratory, in alignment with client Records Retention Policy, as directed by the Sr. Manager of Analytical Services
• Perform all other duties as required


REQUIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:

Bachelor's Degree in Chemistry, Engineering (preferably Biomedical or Chemical), Biological or Natural Sciences, or Pre-Medicine and 0-3 years of related experience (2-3 years related experience preferred
Experience in working with analytical instruments including gas chromatograph, liquid chromatograph, UV-Vis and FT-IR spectrometers, other analytical techniques and mechanical testing equipment is desirable
Experience with working in Quality Assurance / Quality Control, GMP/GLP highly-regulated laboratory testing environment is desirable
Working knowledge of requirements and guidelines associated with GDP and GLP documentation aspects is desirable
Experience with creating, reviewing and approving various high-level laboratory testing-related documentation (operation procedures, test methods, protocols, validations, qualifications, validation / technical reports, etc.)
Experience in working with physical characterization techniques, including microscopy, thermal analysis, and rheology is desirable
Experience with analytical test method development and validation is desirable
Working knowledge of standard laboratory practices and safety
Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentation
Experience with statistics, experimental design and multivariate analyses (and their related software) is desirable
Problem-solving and instrument / method troubleshooting skills are desirable