Data Reviewer (QC Specialist) - CMC

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.

• Perform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the CMC 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

• 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

• Strong experience reviewing analytical techniques such as HPLC, GC, Uv-Vis in a GMP environment
• 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

• This position has no supervisory responsibility

• Frequent supervision and instructions
• Infrequently exercises discretionary authority

• Primarily office (i.e., blend of office and work-from-home)
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

• Ability to work in an upright and/or stationary position for up to 8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
• Occasional mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including office materials and laptop computer with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of any employment Visa at this time.

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.