Interpretation Chemist - US (St Paul) or Germany (Obernburg)

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.

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 Med Tech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global Med Tech 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.

Compensation Target

€60,000.00

Job Description

• Independently analyze data, perform calculations, and interpret test/control results according to written instructions.
• May assist in the interpretation of Feasibility testing, Method Development, and/ or Method Verifications
• Works with management to ensure large studies are completed on or before the due date.
• Maintain ancillary records.
• May trend and evaluate QC data as appropriate.
• Develop and maintain LC-MS compound library and database.
• 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 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, may lead 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.
• Target salary in Germany ~ 60K€
  - Target salary in the US ~ 60K$-70K$

Qualifications & Technical Competencies

Qualifications & Technical Competencies

Your Responsibilities

• Analysis and documentation of received raw data and results
• Performing calculations and interpreting UPLC-MS measurements
• Preparation of objective test reports for submission to clients
• Acting as a point of contact for technical questions from clients and colleagues
• Process improvement and optimization at the site and across locations
• Close collaboration with internal and global colleagues
• Support in the qualification, calibration, and maintenance of equipment, instruments, and tools
• Assistance in the preparation and revision of SOPs, purchasing specifications, protocols, and work instructions
• Help in developing and conducting qualitative and quantitative chemical analysis and experiments using the appropriate equipment and analytical techniques with a primary focus on LC data processing for extractable leachable studies.

Your Qualifications and Skills

• Degree in Chemistry or a related scientific field, ideally with 3 years of professional experience
• Alternatively, technical training in chemistry with at least 3 years of professional experience
• Experience in a GLP environment as well as with DIN EN ISO/IEC 17025 in the field of medical devices is desirable
• Experience handling HPLC and GC-MS instruments is an advantage
• Experience in processing or interpreting UPLC-MS results is beneficial
• High level of initiative and sense of responsibility
• Strong hands-on mentality
• Team player with strong communication skills
• Organizational talent with a structured working style
• Fluent in German and English, both written and spoken

What We Offer

• A challenging and varied role in a globally expanding company
• A highly professional team and an international working environment
• Attractive, performance-based compensation
• Flexible working hours and home office options
• Employer contribution to company pension scheme
• Monthly fuel allowance for private car use
• Electric vehicle charging station
• Regular team events
• Company restaurant with outdoor terrace

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.

The compensation grade range for this position is

• €48,600.00 - €92,700.00
• Annual
• Please

Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.