UPLC Interpretation Chemist - (Talent Pool)

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:
• Operates and maintains a variety of chromatographic and spectroscopic systems such as LC, LC/MS/MS, and GCMS to analyze biological and chemical elements as directed by assays or study protocols.
• May order and/or stock supplies subject to approval. Maintain ancillary records (logbooks, worksheets).
• Conduct routine studies independently according to work instructions. May be requested to conduct more involved studies. Routes all excursions or unusual testing occurrences to management.
• Participate in the improvement of documents, test systems, quality systems, and workflow.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• Assure testing/test article preparation/product is performed within due dates.
• For bio/analytical applications; performs a variety of laboratory techniques including sample weighing and recording, preparation of standard solutions, buffers, sample preparation requiring homogenization, liquid-liquid extraction, filtration, centrifugation and pipetting, etc.
• Validates bio/analytical methods and protocols adhering to GLP guidelines.
• May prepare and maintain reagents and/or test articles as required for testing.
• Maintains an efficient and clean work area by receiving laboratory supplies, organizing and restocking as needed. Maintains logs as necessary for chemical receipt.
• May be required to operate autoclave.
• Maintain relevant supplies and equipment used in routine testing.
• Communicates well with management and other NAMSA Associates to provide test schedule updates, project updates, unusual testing occurrences and other deliverables.
• May trend and evaluate QC data as appropriate.
• In the event of test failure, leads failure investigations identifying root cause and corrective/preventative care.
• May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• May analyze data, perform calculations, and interprets results
• May provide on the job training.
• May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation.
• Validates bio/analytical methods and protocols adhering to GLP guidelines.
• May conduct routine testing per NAMSA SOPs as well feasibility, protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP, etc.
• Works with management to ensure large studies are completed on or before the due date.
• May mentors and train Associates in general laboratory testing as well as offering more complex instrumentation training.
• Review work of other colleagues for scientific soundness and GLP/GMP and SOP compliance.
• May assist with SOP, purchase specification, protocol, and work instruction creation and revisions.
• Helps ensure department compliance to site goals and objectives (i.e. financial, OPD, report revision).
• May be responsible for final report signing.
• May assist with Client Audits as needed.
• Other duties as assigned.
Qualifications & Technical Competencies:
**NAMSA is a rapidly growing, global organization. We are always looking to connect with top talent in our industry. If you are interested in learning more about NAMSA and the FUTURE position below, please apply today!
Principal Duties and Responsibilities

• Independently conduct testing according to written instructions. May be requested to conduct more involved studies.
• May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation.
• May conduct routine testing per NAMSA SOPs as well feasibility, protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP, etc.
• Works with management to ensure large studies are completed on or before the due date.
• Prepare and maintain the reagents required for testing.
• May mentors and train staff in general laboratory testing as well as offering more complex instrumentation training.
• Maintain ancillary records.
• Analyze data, perform calculations, and interprets results
• May trend and evaluate QC data as appropriate.
• May assist with SOP, purchase specification, protocol, and work instruction creation and revisions.
• Participate in the improvement of documents, test systems, quality systems, and workflow.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• Review work of other colleagues for scientific soundness and GLP/GMP and SOP compliance.
• Helps ensure department compliance to site goals and objectives (i.e. financial, OPD, report revision).
• May be responsible for final report signing.
• In the event of test failure, leads failure investigations identifying root cause and corrective/preventive actions.
• May be responsible for client contact with regards to unexpected testing results, project updates, and deliverables.
• Assist with Client Audits as needed.
• Other duties as assigned.

Qualifications and Skills

• Bachelor degree and 3 years of experience, or Master's degree and no experience.
• Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed.

Technical Competencies

• Awareness of applicable guidelines and regulations appropriate for primary job responsibilities, these may include USDA, USP, ICH, EP, and/or JP.
• Knowledge of metric system, scientific applications, experimental design, and data evaluation.
• Can write technical documents and communications (SOPs, protocols, Trackwise records) with minimal management input.
• Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.).
• Ability to work in GMP/GLP environment.
• Helps ensure that department work is compliant with appropriate regulatory standards.

Working Conditions

• Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
• Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
• Physical requirements include being able to frequently move or lift up to 25 pounds.
• Employee must be able to talk and hear.

Working Conditions:
• While performing the duties of this job, the employee is occasionally exposed to sharps and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Eye protection is required in designated areas and when performing specific tasks. The employee may, on rare occasions, be exposed to blood borne pathogens and zoonotic diseases.
• While performing the duties of this job, the employee is regularly required to stand, walk, reach with hands and arms, use hands to finger, handle or feel objects, tools or controls; talk and hear. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. The employee may be required to view computer monitors and stand for extended periods of time.