QC Analytical Senior Scientist
4 weeks ago
POSITION SUMMARY:
The Sr Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP large-molecule manufacturing activities. Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results. The position requires extensive experience within a QC setting and detailed knowledge of GMP/GDP. The associate will perform a variety of responsibilities in both a team and individual setting. This position is an on-site position.
POSITION RESPONSIBILITIES:
- Provides review and approval of analytical test method qualification/validation protocols received from Analytical Technologies (AT) and external method development laboratories.
- Leads the execution of qualification/validation protocols and writes technical reports in collaboration with Analytical Technologies (AT).
- Leads the implementation of programs (e.g. evaluation/implementation of compendial testing).
- Participate in/Support cross-functional projects and teams as a Subject Matter Expert (SME).
- Demonstrates a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, Plate Reader, GC, FTIR, KF, etc.)
- Leads laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.
- Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
- Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
Qualifications
BASIC MINIMUM QUALIFICATIONS:
- Degree in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related discipline: BS 5+ years; MS 3+ year, or PhD with experience working in a GMP laboratory setting.
- Knowledge of compendia (USP, Ph. EUR, and JP) and ICH guidelines.
- Strong written and oral communication skills, proficient with Microsoft Office software.
- Knowledge of compendia (USP, Ph. EUR, and JP) and ICH guidelines.
- Knowledge of fundamental analytical chemistry principles (i.e. use of standards and controls, matrix effects, sample preparation, sample management, calculations, control charting, spectroscopy, chromatography, ELISA, and use of laboratory equipment, protein methods, etc.)
PREFERRED QUALIFICATIONS:
- LIMS experience is highly desired.
- Control/Data trending using statistical tools.
- Experience with ELISA, Bioanalytical and Plate Based Assays
Additional Information
Position is Full Time, Multiple Shifts Available. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for potential yearly Bonus & Merit-Based Pay Increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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