Astrix
3 days ago Be among the first 25 applicants
Position Summary
The Perform analytical testing to support in-process, release, raw material, and stability programs. Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans. Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports. Conduct root cause analyses as part of laboratory investigations and assist in closing quality events. Support regulatory and internal audits as needed. Perform additional duties as assigned. Adhere to all company policies and procedures.
Position Summary
The
QC Analyst II
will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. This person will effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays.
Essential Duties & Responsibilities
Perform analytical testing to support in-process, release, raw material, and stability programs. Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans. Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports. Conduct root cause analyses as part of laboratory investigations and assist in closing quality events. Support regulatory and internal audits as needed. Perform additional duties as assigned. Adhere to all company policies and procedures.
Education
Position Requirements and Qualifications
Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field Minimum of 3+ years of experience
Experience
Hands-on experience working in a cGMP-compliant laboratory. Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays. Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Astrix by 2x Get notified about new Quality Control Analyst jobs in
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The Perform analytical testing to support in-process, release, raw material, and stability programs. Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans. Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports. Conduct root cause analyses as part of laboratory investigations and assist in closing quality events. Support regulatory and internal audits as needed. Perform additional duties as assigned. Adhere to all company policies and procedures.
Position Summary
The
QC Analyst II
will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. This person will effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays.
Essential Duties & Responsibilities
Perform analytical testing to support in-process, release, raw material, and stability programs. Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans. Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports. Conduct root cause analyses as part of laboratory investigations and assist in closing quality events. Support regulatory and internal audits as needed. Perform additional duties as assigned. Adhere to all company policies and procedures.
Education
Position Requirements and Qualifications
Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field Minimum of 3+ years of experience
Experience
Hands-on experience working in a cGMP-compliant laboratory. Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays. Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Astrix by 2x Get notified about new Quality Control Analyst jobs in
Piscataway, NJ . Piscataway, NJ $40,000.00-$200,000.00 1 month ago Quality Document Control Specialist (Cosmetics) - 156698
North Brunswick, NJ $30.00-$35.00 1 day ago Raritan, NJ $93,463.00-$122,670.00 2 weeks ago Middlesex County, NJ $80,000.00-$90,000.00 2 weeks ago QA Label Control Specialist- Pharma (Onsite- Summit, NJ)
Branchburg, NJ $64,000.00-$122,000.00 4 days ago Cranbury, NJ $294,000.00-$352,666.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 2 days ago Cranbury, NJ $50,000.00-$70,000.00 1 week ago Inventory Control Quality Control Associate - Edison, NJ
Middlesex County, NJ $75,000.00-$90,000.00 6 days ago Senior Regulatory Compliance/ Quality Assurance
Roselle, NJ $100,000.00-$110,000.00 2 weeks ago Bridgewater, NJ $73,000.00-$97,200.00 6 days ago Old Bridge, NJ $63,300.00-$91,700.00 2 weeks ago East Hanover, NJ $83,800.00-$115,225.00 1 week ago North Brunswick, NJ $21.00-$31.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr