The Role
Perform QC technical, scientific, and compliance review of bioanalytical data in a GxP environment. Identify deviations, OOS/OOT, issue QC observations, liaise with scientific staff to ensure data integrity, collect QC metrics, and support process improvements and staff education on GxP best practices.
Summary Generated by Built In
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell work, gene therapy and more.
We are looking for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly organized. If you influence others by being a trusted advisor and advocate, are energized by a deadline-driven environment, and aspire to provide the best caliber of data to our customers, then you’ll be right at home here at BioAgilytix.
Essential Responsibilities
- Perform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP).
- Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
- Issue QC review observations and work closely with the scientific staff to ensure data integrity
- Collect metrics data used to monitor the QC reviews, and may identify process improvements
- Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance
Minimum Preferred Qualifications: Education/Experience
- Bachelor’s degree in biological science or related field, with between 2-10 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization; or Master’s or PhD. with equivalent experience
- Knowledge and/or extensive knowledge of GxP regulations
- Two-Four (2-4) years’ experience performing data review in a GxP environment
- Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
Minimum Preferred Qualifications: Skills
- Self-motivated and demonstrated ability to learn and work in a fast-paced environment where multiple concurrent projects must be completed in a timely manner
- Ability to perform your role independently with attention to detail and minimal oversight
- Ability to perform technical review of data following GxP regulations and scientific principles
- Expertise in communicating and building relationships with others, where all feel heard and respected
- The confidence to make and share observations in a considerate manner
- Proficiency in LIMS and Quality Management software packages
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use.
Skills Required
- Bachelor's degree in biological science or related field (or Master's/PhD with equivalent experience)
- 2-10 years' experience in biotech, pharmaceutical, CRO/CMO or similar organization
- Knowledge and/or extensive knowledge of GxP regulations (GLP/GMP)
- Two-Four (2-4) years' experience performing data review in a GxP environment
- Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
- Proficiency in LIMS and Quality Management software packages
- Ability to perform technical scientific review of data following GxP regulations and scientific principles
- Ability to identify deviations, OOS and OOT and issue QC review observations
- Experience collecting metrics used to monitor QC reviews and identifying process improvements
- Strong communication and relationship-building skills; ability to educate and influence scientific staff
- Self-motivated, able to work independently with attention to detail and minimal oversight
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
.png){kind=logo}
