Senior QA Specialist I

WuXi Biologics Group; New Jersey; Hybrid; USD 72,000 - 116,000; Full time

Job summary

WuXi Biologics Group in New Jersey is seeking an experienced QA/QC professional to lead quality activities in a biopharmaceutical facility. You will collaborate with Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues and ensure GMP standards are met.

The ideal candidate holds a Bachelor/Master/PhD in Biochemistry or related science with 8+ years in QC/QA, plus familiarity with TrackWise and MasterControl.

Qualifications

• 8+ years of QC/QA experience in a biopharmaceutical facility.
• Knowledge of FDA/EMA regulations, ICH and cGMP guidelines is a plus.
• Good oral and written communication skills in English.

Responsibilities

• Build and maintain relationships with cross-functional teams to resolve quality issues.
• Ensure compliance with SOPs and production requirements.
• Support client PIP and client QA during client visits.
• Attend regular department/global/client meetings as required.
• Seek management guidance on complex issues.

Education

Bachelor/Master/PhD in Biochemistry or related science

Tools

TrackWise

MasterControl

Job description

• Build and maintain relationships with cross-functional teams including Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues to maintain quality standards.
• Ensure compliance with applicable SOPs and production requirements
• Support client PIP and client QA during Client visit.
• Attends regular department/global/client meetings as required or assigned.
• Seeks management guidance on complex issues.

Qualifications:

• Bachelor, Master or PhD degree Biochemistry or other related science discipline
• 8+ years working experience as QC or QA in a Biopharmaceutical facility
• Knowledge of TrackWise and MasterControl is desired.
• Knowledge of FDA and EMA regulations, ICH and cGMP guidelines is a plus
• Knowledge of Biopharmaceutical manufacturing is desired.
• Good Oral and Written communication skills in English
• Good interpersonal communication skills, good organizational skills

The anticipated salary range for this position is $72,000-116,000

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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