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QC Analytical Chemist - Level 2
Verona, WI
Job Description
POSITION OVERVIEW:
The QC Analytical Chemist - Level 2 will primarily assist the Production and Formulations Departments by analyzing pharmaceutical samples delivered to the QC laboratory. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support product development, clinical trials, stability studies, and process validations. The QC Analytical Chemist - Level 2 is expected to understand internal procedures and reliably conduct more complex analyses with little or no supervision after training. Additionally, the QC Analytical Chemist - Level 2 assists Level 1 Chemists with basic analyses as needed.
The QC Analytical Chemist - Level 2 assists in maintaining the operation and calibration of analytical equipment as well as maintains overall cGMP compliance within the QC laboratory. The QC Analytical Chemist - Level 2 will also perform instrument qualifications and contact equipment vendors with minimal supervision.
The QC Analytical Chemist - Level 2 is expected to have a more thorough understanding and assist CPI management and/or other lab personnel to ensure Level 1 Chemists follow and understand internal laboratory procedures.
ESSENTIAL JOB FUNCTIONS:
EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
The QC Analytical Chemist - Level 2 will primarily assist the Production and Formulations Departments by analyzing pharmaceutical samples delivered to the QC laboratory. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support product development, clinical trials, stability studies, and process validations. The QC Analytical Chemist - Level 2 is expected to understand internal procedures and reliably conduct more complex analyses with little or no supervision after training. Additionally, the QC Analytical Chemist - Level 2 assists Level 1 Chemists with basic analyses as needed.
The QC Analytical Chemist - Level 2 assists in maintaining the operation and calibration of analytical equipment as well as maintains overall cGMP compliance within the QC laboratory. The QC Analytical Chemist - Level 2 will also perform instrument qualifications and contact equipment vendors with minimal supervision.
The QC Analytical Chemist - Level 2 is expected to have a more thorough understanding and assist CPI management and/or other lab personnel to ensure Level 1 Chemists follow and understand internal laboratory procedures.
ESSENTIAL JOB FUNCTIONS:
- Assists CPI management and/or other lab personnel with method development and qualification activities (i.e. method validations, compendial verifications, method transfers, etc.)
- Supports product and method development, stability studies, and/or process validations.
- Analyzes pharmaceutical samples.
- Performs method development, analytical method, and instrument qualifications.
- Assists Level 1 Chemists with basic tasks.
- Drafts protocols, summary reports, and new or existing internal procedures and/or specifications.
- Provides formal notifications and reports to CPI management.
- Maintains a cGMP laboratory notebook and forms.
- Reviews laboratory notebooks and forms of other lab personnel.
- Calibrates and maintains QC analytical equipment.
- Contacts QC analytical equipment vendors.
- Assists in maintaining a clean, organized QC laboratory.
- Lifts/Carries objects weighing up to 55 lbs.
- Follows all CPI cGMP practices, policies, and procedures.
- Follows all CPI safety practices, policies, and procedures.
- Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
- Bachelor's degree in chemistry or related field.
- 2+ years of experience in a cGMP pharmaceutical environment. An advanced degree may be substituted in place of experience.
- Basic understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities.
- Experience with the use and troubleshooting of analytical equipment (i.e. HPLC, GC, and/or dissolution apparatus) desirable.
- Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.
- Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.
- Ability to lift object weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
2+ years
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