- Perform sample analysis, interpret results, and review data packages.
- Perform testing for qualification and re-qualification of reference materials.
- Assist with method development activities, draft method qualification/validation protocols for analytical procedures and for instrument qualifications.
- Transfers and qualifies analytical methods with guidance from experienced team member.
- Prepare high quality written documentations (notebooks, CoTs, summary reports, SOPs, and analytical procedures).
- Troubleshoots analytical instrumentation.
- Communicate effectively in verbal and written form on research results and plans.
- Volunteer to assist with task not directly related to a specific project.
- Demonstrate initiative in handling responsibilities.
- Contribute to the technical growth of the department and company.
- Demonstrate technical proficiency and self-assuredness in applying cGMP standards and ensuring all documentation produced follows cGMP standards.
- Ensure work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
- Technical and procedural proficiency and self-assuredness in applying EH&S standards and procedures in association with department specific responsibilities is required.
- Responsible for contributing to audit readiness and for participating in Quality and EH&S audits with internal Company groups, regulatory agencies, and customers is essential.
- Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
- To carry out any other duties which are within the employee's skills and abilities whenever reasonably instructed.
- BS in Analytical Chemistry or equivalent is required.
- Must have 0-3 years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
- Experience with common analytical techniques such as: HPLC, GC, NMR, UV, KF, FTIR is required.
- Good written and verbal communication skills are required.
- Ability to write clear and concise technical reports is crucial.
- Must have a good understanding of Microsoft Office and statistical software.
- Demonstrates ability to exercise good judgment and make decisions quickly.
- Ability to work independently and in a team environment.
- Knowledge of MS Project is preferred.
- Must have experience in establishing integrated plans with resource and task constraints.
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Must be able to lift and/or move up to fifty pounds.
- Specific vision abilities include near, distance, peripheral, color perception, and the ability to adjust focus is needed.
- Must be able to regularly works with moving mechanical parts and may work with toxic or caustic chemicals.
- It may be required to work in humid areas with low or high temperatures and may require working with respirator or operating with bunny suits.
- Must be able to work various shifts and/or when night and weekend coverage is needed.
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Analytical Chemist - Devens, United States - Veranova L P
Description
Job Description
Job DescriptionCompany Description
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Job Description
The Analytical Chemist is responsible for the implementation of analytical procedures in support of sample testing, method development, method qualification/transfer/validation, GMP/n-GMP production, reference material program, metrology, and stability testing with particular emphasis on LC, GC, KF, NMR, FTIR, XRPD methods for Active Pharmaceutical Ingredients (APIs). The Analytical Chemist will support the functions include sample analysis by a variety of analytical techniques with respect to potent compound.
Key Responsibilities / Accountabilities
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
