QC Stability Specialist II - Data, CAPA & QA Lead

CED Analytical Laboratory Inc.; Irving (TX); On-site; USD 65,000 - 86,000; Full time

Benefits offered by this job

PTO and holidays

Group health plan

401k plan

Employee referral program

Company events

Job summary

CED Analytical Labs in Irving, TX is seeking a QC Specialist II to coordinate the stability program, record testing data, pull samples, and generate CoAs and trend reports. You will also review data, perform investigations, deviations, CAPAs, and support internal and external audits.

The role requires a BS in Chemistry or related field, 3+ years in pharma QC, experience with cGMP/GLP and LIMS, and strong MS Office skills. We offer PTO, health benefits, 401k, and growth opportunities.

Qualifications

• Bachelor of Science in Chemistry or a science-related field is required.
• Minimum of three (3) years in a pharmaceutical environment/cGMP laboratory.
• Two (2)–five (5) years in Quality Control and experience reviewing analytical data.
• Working knowledge of cGMP/GLP, USP/NF, ICH and FDA regulations; proficiency with LIMS and MS Office.

Responsibilities

• Maintain documentation for stability samples, including testing records, protocols, and trend reports.
• Place new samples on stability, pull samples for testing, and generate CoAs/trend reports for completed testing.
• Initiate and complete deviations, CAPAs, investigations, and change controls related to the stability program.
• Perform data review on analytical testing and generate Certificates of Analysis for routine QC and stability studies.
• Assist with internal and external audits and support quality operations as needed.

Skills

Organizational skills

Prioritization

Detail oriented

Independent work

Education

Bachelor of Science in Chemistry or related field

Tools

LIMS

Microsoft Office

Job description

CED Analytical Labs in Irving, TX is seeking a QC Specialist II to coordinate the stability program, record testing data, pull samples, and generate CoAs and trend reports. You will also review data, perform investigations, deviations, CAPAs, and support internal and external audits.

The role requires a BS in Chemistry or related field, 3+ years in pharma QC, experience with cGMP/GLP and LIMS, and strong MS Office skills. We offer PTO, health benefits, 401k, and growth opportunities.