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.
In this role, you will champion quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data is delivered. You will ensure standard methods and protocol requirements are met through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in approach, then advise on corrective action, which leads us to the ultimate goal of data quality and integrity for our customers.
We are looking for candidates who have large molecule, bioanalytical, and QA experience in a deadline-driven and regulated GxP setting. The best candidates are fast learners, quantitative thinkers, and doers. If you are a person who influences others in a way that feels like a trusted advisor and advocate, is energized by collaboration, sees the big picture, and aspires to provide the best caliber of data to our customers, then you’ll be right at home here at BioAgilytix.
Essential Responsibilities
- Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
- Issue QA statements for reports as needed
- Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
- Assist in writing and reviewing QA standard operating procedures
- Positively impacts the company through successful contributions, active participation and identification of compliance gaps
- Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
- Assist in document management activities
- Perform duties with minimal QA Management oversight
Additional Responsibilities
Minimum Preferred Qualifications - Education
- Bachelor’s degree in biology, chemistry, biochemistry, medical technology, or other scientific discipline
- Not less than two (2) years’ experience working in a laboratory/bench role/operations
- Not less than two (2) years’ experience in GLP/GCLP quality assurance (QA)
- Experience working in biotech, pharmaceutical, CRO/CMO or similar organization
Minimum Preferred Qualifications - Skills
- Internal and/or external GxP auditing experience
- Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
- Excellent verbal and written communication skills
- Ability to deal effectively with a diversity of individuals at all organizational levels
- Acute attention to detail
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
Supervisory Responsibility
- This position has no supervisory responsibilities
Supervision Received
- Frequent supervision and instructions
- Infrequently exercises discretionary authority
Working Environment
- Primarily office
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
- Occasional weekend, holiday, and evening work required
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 lab 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
- 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
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 (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.
