IntePros · 11 hours ago
Laboratory Investigation Analyst
IntePros is currently looking for a Laboratory Investigation Analyst to join one of their growing Medical Device/Manufacturing clients. The Laboratory Investigation Analyst will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques, as well as assisting in the development of procedures and supporting the laboratory team in administration and quality systems.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating procedures (SOPs)
Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems
Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations
With guidance, assist in completing projects from protocol to final report
Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner
Train new analysts as appropriate
Exercises creativity in developing new test / debugging methods
Keep current with new analytical techniques and technology
Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols
Apply internal QA procedures and perform lab investigations, OOS, and OOT as required
Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required
Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude
Support laboratory management in data quality-documentation, and archiving
Maintain compliance to cGMP and ISO requirements and established safety procedures
May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry
May handle Test Requests – write, review, and approve, and maintain traceability of samples
Qualification
Required
High School Diploma required
0 - 3 years of experience required
Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating procedures (SOPs)
Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures
Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations
With guidance, assist in completing projects from protocol to final report
Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner
Train new analysts as appropriate
Exercises creativity in developing new test / debugging methods
Keep current with new analytical techniques and technology
Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols
Apply internal QA procedures and perform lab investigations, OOS, and OOT as required
Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required
Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude
Support laboratory management in data quality-documentation, and archiving
Maintain compliance to cGMP and ISO requirements and established safety procedures
May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents
Proficiently use MS Office products for data gathering, reporting, and data entry
May handle Test Requests – write, review, and approve, and maintain traceability of samples
Preferred
Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
Experience working in a laboratory or cGMP/pharmaceutical environment preferred
Laboratory administrative/Coordinator/Analyst role preferred
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
Method development and validation
Willingness to learn and apply new analytical techniques
Proficient in Microsoft Office tools and capable to learn other software programs
Able to review regulatory code and learn safety standards
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Able to comply with the company's safety and quality policies at all times
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageCompany data provided by crunchbase