QC Analyst IV

Unicon Pharma Inc; Portsmouth (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

Unicon Pharma Inc. in Portsmouth, NH seeks an experienced QC Analyst IV to support in-process, final product testing and stability studies. You will deliver accurate results on time while handling broader scope and supporting special projects.

The role involves mentoring junior analysts, troubleshooting lab issues, and ensuring GMP, data integrity (ALCOA+), and audit readiness. Experience with HPLC/UPLC and analytical methods is required.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.
• Strong GMP/cGMP QC laboratory experience.
• Hands-on experience with HPLC and/or UPLC.
• Experience with analytical testing, data review, and troubleshooting.
• Knowledge of Data Integrity, ALCOA+, GMP, and regulatory requirements.
• Experience supporting OOS/OOT investigations, deviations, CAPA, and change controls.
• Excellent communication and ability to work independently.
• Experience with electrophoresis, icIEF, PCR, or spectrophotometry is a plus.

Responsibilities

• Perform and review analytical testing for in-process, final product, and stability samples.
• Execute assays within the HPLC Analytical and Electrophoresis laboratories.
• Operate and troubleshoot Agilent and Waters HPLC/UPLC systems.
• Support laboratory equipment maintenance, calibration, troubleshooting, and vendor activities.
• Provide guidance, training, and feedback to junior QC analysts.
• Delegate tasks and support daily laboratory operations.
• Work independently on complex QC activities and special projects.
• Support OOS/OOT investigations, deviations, CAPA, and change controls.
• Identify and implement laboratory improvements (6S, document revisions, work orders).
• Collaborate with QA, Manufacturing, MSAT, and other cross-functional teams.
• Maintain GMP, Data Integrity, ALCOA+, and audit-readiness.
• Participate in pre-audit activities and support auditors as a QC SME.
• Review analytical data and laboratory documentation for accuracy.
• Complete assigned work accurately and on time with minimal direction.

Skills

GMP/cGMP QC

HPLC/UPLC

Data review

Documentation

Cross-functional collaboration

Troubleshooting

Education

Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field

Tools

Agilent instruments

Waters HPLC/UPLC systems

Job description

We are seeking an experienced QC Analyst IV to support QC operations, including in-process and final product testing and ongoing customer stability studies. The role requires delivering accurate, high-quality results on time while handling tasks of increased scope, supporting special projects, troubleshooting laboratory issues, and providing technical support to team members.

Key Responsibilities

• Perform and review analytical testing for in-process, final product, and stability samples.
• Execute assays within the HPLC Analytical and Electrophoresis laboratories.
• Operate and troubleshoot Agilent and Waters HPLC/UPLC systems and other laboratory instruments.
• Support laboratory equipment maintenance, calibration, troubleshooting, and vendor activities.
• Provide guidance, training, and feedback to junior QC analysts and team members.
• Delegate tasks and support daily laboratory operations.
• Work independently on complex and varied QC activities and support special projects.
• Support OOS/OOT investigations, deviations, change controls, and CAPA as required.
• Identify and implement laboratory improvements, including 6S, document revisions, work orders, and change controls.
• Collaborate with QA, Manufacturing, MSAT, and other cross-functional teams and es
• Maintain GMP, Data Integrity, ALCOA+, and audit-readiness requirements.
• Participate in pre-audit activities and confidently support auditors as a QC SME.
• Review analytical data and laboratory documentation for accuracy, completeness, and compliance.
• Complete assigned work accurately and on time with minimal direction.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field, or equivalent relevant experience.
• Strong GMP/cGMP QC laboratory experience.
• Hands-on experience with HPLC and/or UPLC.
• Experience with analytical testing, data review, and laboratory troubleshooting.
• Knowledge of Data Integrity, ALCOA+, GMP, and regulatory requirements.
• Experience supporting OOS/OOT investigations, deviations, CAPA, and change controls.
• Strong written and verbal communication skills.Ability to work independently, prioritize tasks, solve problems, and collaborate effectively with cross-functional teams.
• Experience with electrophoresis, icIEF, PCR, spectrophotometry, or other advanced analytical techniques is a plus.