To apply, please also email your resume to MFG18Careers.US@wuxibiologics.com
The following job description applies to the position, department and business unit as stated below:
Job Title: Senior Associate – QC Analytical Testing
Location: New Jersey , USA
Site/Department: Cranbury MFG 18/QC
Business Unit or Division: WuXi Biologics Development
II. Job Summary
The Senior QC Associate will support material and product release testing within the QC analytical laboratory. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing assays for materials and products. Additionally, the Senior QC Associate will investigate and review excursions and deviations generated during qualification and testing.
III. Job Functions
- Work cross-functionally with Analytical Development to qualify and transfer developed assays.
- Draft and review qualification/validation methods as well as associated test methods/SOPs and reports.
- Perform routine analytical tests, analyze results, and record data/report in LIMS.
- Collaborate with other QC functions to ensure all testing is completed within established timelines.
- Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
- Assist in the training of laboratory staff.
IV. Job Requirement
- Master’s degree in a technical discipline (Biology/Chemistry/Microbiology or related field) or 3+ years of experience or equivalent for Bachelor’s degree.
- Experience in assay development and troubleshooting.
- Experience in drafting test methods and associated qualifications/validations.
- Experience in performing laboratory investigations.
- Ability to work independently and communicate/collaborate with scientific/technical personnel.
- Excellent organizational skills and attention to detail.
- Significant knowledge of GMPs, SOPs, and Quality System processes.
- Experience working with electronic systems (LIMS, QMS, ERP) is a plus.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.