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.
Essential Responsibilities
- Perform Quality Control (QC) compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GxP).
- Review data for compliance with the validated method and for consistent chromatography and integration.
- 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.
- Follow QCT SOPs
Additional Responsibilities
Minimum Preferred Qualifications: Education
- Bachelor’s degree in biological science or related field or five (5+) years’ experience working in a GxP regulated environment with relevant experience.
Minimum Preferred Qualifications: Experience
- Not less than four (4) years’ experience working in biotech, pharmaceutical, CRO or similar organization
- Knowledge of GxP regulations
- Experience with relevant bioanalytical methods such as HPLC, LC/MS/MS, etc.
- Experience performing data review in a GxP environment
Minimum Preferred Qualifications: Skills
- Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
- Ability to take direction well and multi-task
- Acute attention to detail and organizational skills
- Excellent oral and written communication skills
- Proficiency in MS Excel and Word
- Proficiency in LIMS and Quality Management software packages
Supervisory Responsibilities
- This position has no supervisory responsibilities
Supervision Received
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
Working Environment
- Primarily office (i.e., blend of office and work-from-home)
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Physical Demands
- Ability to work in an upright and/or stationary position for up to eight (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
Position Type and Expected Hours of Work
- 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
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability jobs-near-me.org Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 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.
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