1532 QC Analyst 3
$120,640–$133,058 year
On-sitePortsmouth, New Hampshire, United States
Job Summary
Provide feedback and guidance to junior analysts on procedures, compliance, and daily tasks while delegating and coordinating work to balance laboratory operations. Maintain equipment readiness by managing maintenance, calibration, and vendor activities for systems like HPLC, UPLC, and PCR analyzers, then troubleshoot instrument and software issues as needed. Execute advanced assays in the HPLC Analytical and Electrophoresis labs, perform data reviews, and initiate investigations for quality events or deviations. Drive audit readiness through pre-audit walkthroughs and act as a QC subject-matter expert during inspections, ensuring all work adheres to cGMP and Data Integrity principles.
Required Qualifications
- Bachelor's degree in Biochemistry or a related scientific field
- Advanced level (5–10 years) industry experience, preferably in a cGMP environment
- Willingness to take on new challenges and adapt thinking/behavior to support change
- Supports continuous process improvement and problem solving
- Proposes ideas to improve business area and interprets data effectively
- Comfortable speaking publicly and making basic quality decisions independently
- Works as an active team member, values different perspectives, shares knowledge, and treats coworkers with respect
- Understands internal and external customer needs and delivers accordingly
- Ensures quality standards are maintained, consistently delivers goals while monitoring KPIs
- Plans, prioritizes, and organizes work effectively
- Demonstrates safety responsibility and professionalism; acts as an example to other analysts
- Must adhere to cGMPs at all times
- Must follow job safety procedures, attend required health and safety training, proactively promote safety, and promptly report incidents
- Must comply with site safety policies
- Ability to comprehend and follow written and verbal instructions
- Exercise judgment within defined procedures to determine appropriate action
- Strong data interpretation skills, independently and with guidance
- Punctual and able to work full assigned shifts
- Strong written and verbal communication skills
- Self-motivated team player with a positive and professional attitude
- Complete assignments on time and accurately with minimal rework
- Commitment to quality and performance excellence
- Ability to perform complex and varied tasks, prioritize work, solve problems, and plan/coordinate tasks and projects
- Facilitate brainstorming and continuous improvement initiatives
- Apply Data Integrity principles in all tasks and maintain audit-ready documentation
- Participate in pre-audit walkthroughs and support audits as QC SME
- Submit resume and cover letter demonstrating experience in cGMP laboratory testing, instrument operation (list relevant systems), and examples of cross-training, troubleshooting, or audit support
Desired Qualifications
- A combination of education and additional years of relevant experience
- Professional certifications
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