Method Validation Chemist II
- Job Title
- Method Validation Chemist II
- Job ID
- 27697082
- Location
- Clearwater, FL 33760
- Other Location
- Description
-
WHY CORERX?
CoreRx is a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx, our biggest asset is our people, and the service and solutions they provide to our partners; you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people - team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a result-oriented focus, and ethical behavior.
OUR EMPLOYEES ENJOY A COMPETTIVE BENEFITS PACKAGE, INCLUDING:- Competitive compensation with an annual discretionary incentive bonus!
- Affordable healthcare insurance (Medical, Dental, Vision)
- Health Care Flexible Spending Account
- Employer paid LTD, STD, and Life Insurance Coverage
- Paid Time Off (PTO), 15 days prorated your first year
- 401K with employer match
- Tuition Reimbursement, Perks at Work Employee Discounts, Employee Assistance Program, and Adoption Assistance Program
As an essential part of the CoreRx Method Validation team, the Method Validation Chemist III will design and execute method validation activities according to effective protocols. This includes, but not limited to, establishing notebook templates, planning and documenting the execution of the activities, processing and compiling the data for QA review and the associated validation report and updating the test method based on validation results.
ESSENTIAL JOB DUTIES- Capability of carrying out independent work. Exercises diligence within defined practices and policies described in CoreRx SOPs in selecting techniques and evaluation criteria.
- Validation, verification, and transfer of analytical methods for QC testing of API and finished product.
- Execution of validation protocols and writing as needed and generation of summary reports.
- Development and revision of work instructions, test methods, and other technical documentation as needed.
- Assists chemists and other laboratory personnel in design and interpretation of experiments or project (as needed).
- Training of laboratory staff as needed.
- Review or secondary review of laboratory data.
- Set up and operation of both basic lab equipment and more advanced instrumentation such as GC and HPLC.
- Treats data with a high level of integrity and ethics.
- Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
- Troubleshooting of instruments and laboratory equipment.
- Participates in moderate to extensive problem solving which requires original thought. Prepares reports with interpretation and can interpret the results of complex experiments.
- Maintenance of all required reagents and standards for current projects.
- Performs other related duties as assigned by management.
WORK EXPERIENCE REQUIREMENTS- 4 years’ experience in pharmaceutical analytical testing including: Experience with GC, HPLC, Dissolutions, Assay, Related Substances, Content Uniformity, Blend Uniformity
- Experience and well-versed in GMP
- Experience in validating, performing quantitative and qualitative analysis by GC
- Experience writing technical documents such as reports, protocols, reports, test method
- Bachelor of Science or better in Chemistry or related field
PHYSICAL DEMANDS
Physical: Primary functions require sufficient physical ability and mobility to work in a laboratory setting; to stand or sit for prolonged periods of time; to occasionally stoop, bend, kneel, crouch, reach and twist; to lift, carry , push, and/or pull light to moderate amounts of weight; to operate laboratory and office equipment requiring repetitive hand movement and find coordination including use of a computer keyboard; and to verbally communicate to exchange information; requires the wearing of personal protective equipment including safety glasses or goggles, lab coats, rubber or plastic globes, respirators or face shields.
Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents; to operate assigned equipment and to distinguish color.
Hearing: Hear in the normal audio range with or without correction. Must be able to read, write, speak and understand the English language.
Safety: Must be able to wear proper protective equipment.
WORK ENVIRONMENT
Environment: Work is performed primarily in a laboratory setting; exposure to dusts, fumes, moderately high levels of toxic chemicals and solvent; work with laboratory equipment and apparatus.
NOTIFICATION TO AGENCIES
Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referrable compensations.