Scientist, Quality Control Operation

WuXi Biologics Group; New Jersey; On-site; USD 60,200 - 96,300; Full time

Job summary

A leading biopharmaceutical company in New Jersey seeks a Scientist for QC Operations. You will be responsible for managing QC sample handling, ensuring compliance with GMP regulations, and mentoring junior staff. An ideal candidate holds a Bachelor’s degree in a relevant field with 4+ years experience. Strong organizational, critical thinking, and time management skills are essential. The salary range for this position is $60,200 to $96,300, and the role offers opportunities for professional growth.

Qualifications

• 4+ years of experience in a related professional field, or 2+ years with a Master's degree.
• Skills in reading, writing, and understanding GMP documentation.
• Experience with confidentiality and responsibility.

Responsibilities

• Manage QC sample and stability samples, including receiving, storage, and disposal.
• Perform technical reviews of stability study protocols and sampling plans.
• Ensure compliance with QC operation documentation and training.

Skills

Attention to detail

Organizational skills

Critical thinking

Time management

Scientific reasoning

Problem-solving

Education

Bachelor's degree in biology, chemical engineering, chemistry, pharmacy or related majors

Master's degree

Tools

LIMS

TrackWise

Job description

The Scientist-QC Operations will be responsible for QC sample management, RS management, and QC stability study program to support QC GMP activities, including but not limited to in-time and properly sample/RS receiving, aliquoting, storage, and distribution for testing, and stability study protocol writing/reviewing/revising, stability sample receiving, aliquoting for stability study initiation, storage, pulling, aliquoting and distribution for testing in time and correctly to ensure on-time delivery of test results, validation data and other QC deliverables to internal and external clients. Also as inventory management QC GMP documentation archive backup to support QC inventory management and QC GMP documentation archive as needed. Strong communication, detail orientation, and time management skills are desired.

Responsibilities

• Responsible for QC sample management, including but not limited to receiving, storage, aliquoting, distributing, tracking, and disposing of QC testing sample and reference standards.
• Responsible for stability sample management, including but not limited to sample receiving, aliquoting, distributing, tracking, and disposing of stability backup sample.
• Responsible for reference standard (RS) management, including RS receiving, aliquoting, storage, and distribution.
• Perform technical review of sampling plans, stability study protocols, RS aliquoting, qualification and re-qualification protocols.
• Perform RS, regulatory retain sample, and stability samples annual inventory checking.
• Coordinate with QC Functional Leads (QCFL) to ensure timely cleanup, reconciliation, and disposal of project-related stability and RS samples upon project completion.
• Support QC lab inventory management, including but not limited to QC lab inventory ordering, receiving, storage, distribution, inventory tracking.
• Ensure compliance with QC operation related documentation and training for company's requirements.
• Request sample/RS and stability management-related control paper forms and logbooks for sample storage refrigerators, freezers and chambers from QA as needed.
• Maintain all refrigerators/freezers used for sample/RS/stability sample storage, keeping them well organized and clean and responding to alarms and executing corrective actions to protect sample integrity.
• Responsible for weekly in-process sample clean up and disposal.
• Perform all activities in compliance with applicable safety policies, quality systems, and cGMP requirements.
• Mentor junior QC operation staff and provide technical guidance and support.
• Perform other duties assigned by management to support overall QC operations.

Qualifications

• Bachelor's degree: 4+ years of experience in the related professional field. Master's degree and above: 2+ years of experience in the related professional field.
• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
• Be skilled at reading, writing, and understanding GMP documentation.
• Strong attention to detail and organizational skills.
• Broad knowledge and experience in GMP regulations.
• High awareness of confidentiality and responsibility.
• Detail oriented and effective time management.
• Critical thinking, scientific reasoning, planning and problem-solving skills.
• Experience with a wide variety of software and information systems (e.g. LIMS, TrackWise, MC, etc.).
• Be able to work independently as well as a good team player.

Salary range for this position is 60,200-96,300

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