QC Stability Specialist II – Data Integrity & CAPA

Medisca; Irving (IA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

PTO and vacation policy

Group health benefits

401(k) plan

Employee referral program

Company events

Job summary

Medisca, in partnership with CED Analytical Labs in Irving, TX, seeks a QC Specialist II to manage stability testing, data review, and certificate generation. The role supports internal audits, CAPAs, and regulatory compliance within a cGMP laboratory setting.

Responsibilities include maintaining stability documentation, coordinating sample testing, generating CoAs and trend reports, and participating in both internal and external audits.

Qualifications

• Bachelor of Science in Chemistry or related field.
• Minimum three (3) years in a pharmaceutical environment/cGMP laboratory.
• Two (2)–(5) years in Quality Control.
• Experience with reviewing analytical chemistry data.
• Knowledge of cGMP/GLP, USP/NF, ICH and FDA regulations.
• Knowledge of Laboratory management systems (LIMS).
• Proficient in Word, Outlook, Teams and Excel.

Responsibilities

• Maintain stability sample documentation and testing records.
• Place new samples on stability and pull samples for testing; generate CoAs/trend reports.
• Initiate deviations, CAPAs, investigations, OOS, and change controls.
• Review analytical data and generate CoAs for routine QC and stability testing.
• Generate trend reports for stability studies.
• Assist with internal facility and system audits and external audits.
• Support other quality projects and operations as needed.

Skills

Attention to detail

Communication skills

Fluent English

Education

Bachelor of Science in Chemistry or science-related field

Tools

LIMS

Microsoft Office

Job description

Medisca, in partnership with CED Analytical Labs in Irving, TX, seeks a QC Specialist II to manage stability testing, data review, and certificate generation. The role supports internal audits, CAPAs, and regulatory compliance within a cGMP laboratory setting.

Responsibilities include maintaining stability documentation, coordinating sample testing, generating CoAs and trend reports, and participating in both internal and external audits.