ANALYTICAL QC CHEMIST III
- Job Title
- ANALYTICAL QC CHEMIST III
- Job ID
- 27682033
- Location
- Clearwater, FL 33760
- Other Location
- Description
-
WHY CORERX
CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx 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 results-oriented focus and ethical behavior.
If we do not have any positions that fit your needs at this time; We invite you to join our talent network and stay informed about future opportunities by submitting your resume.
Thank you for choosing CoreRx as your employer of choice.
DESCRIPTIONThe Analytical Chemist III is an integral part of the team, contributing to our success by performing raw materials and clinical and commercial pharmaceutical products testing according to compendial method and/or methods provided by analytical development team or clients. Familiar and participates in method validation and transfer activities within departments or between facilities or organizations.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Performs relevant QC testing, such as HPLC, GC, Dissolution, Malvern and wet chemistry testing as required in compliance with cGMP requirements, compendia standards, and internal procedures
- Ensures testing is properly conducted and documented for all performed activities with emphasis on data integrity
- Prepare test solutions, volumetric solutions, and samples used in analysis
- Performs assigned physical tests, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products in an FDA regulated lab environment
- Performs QC related method validations and tranfer activities
- Author and review SOP's, test methods, protocols and summary reports
- Perform analysis with a practical understanding of the test procedure and instrument operation
- Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results
- Conducts laboratory investigation under the supervision of laboratory manager.
- Complies with all regulatory/ in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, documentation
- Maintain required level of training needed to perform a GMP task
- Provide training and support to peers within the analytical group
- Performs complex procedures independently
- Notify manager immediately of nonconforming data or unexpected occurrences
- Organize work schedule to complete assigned tasks efficiently and on schedule
- Work under direction provided by manager
- Conscientious with safety procedures and knowledgeable of hazardous waste procedures
- Performs other related duties as assigned by management
EXPERIENCE AND EDUCATION REQUIREMENTS - Experience in UPLC/HPLC GMP operations
- Experience in trouble shooting techniques for HPLC, GC, etc.
- Knowledge with analytical equipment and Part 11 compliant software, such as Chemstation™, Chromeleon™, EMPOWER™, and Laboratory Information Management System
- Familiar with current ICH and USP guidance for analytical method validations
- BS/BA in life science or chemistry required
- MS/MA in life science or chemistry preferred
- Equivalent experience may substitute for stated requirement
PHYSICAL DEMANDS- Regularly required to stand. Frequently required to sit, walk, talk, hear, handle or feel tools or controls
- Occasionally required to reach with hands and arms, stoop, crouch, climb or balance, kneel
- Vision suitable for performing detailed inspections
- May be required to move items weighing up to 25 lb.
- Ability to communicate clearly in both written and verbal form
We are an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and State laws, regulations, and executive orders regarding nondiscrimination and affirmative action with our hiring activities. We do not discriminate based on race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status.
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 referral compensations.