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.

We're seeking a detail-oriented and proactive Corporate Compliance Specialist to join our team. In this role, you'll play a crucial part in supporting various Corporate Compliance and Archivist activities. Key responsibilities include serving as a backup archivist, providing assistance for data audits, supporting sponsor audits, aiding in internal audits , and handling onboarding duties. The ideal candidate brings experience working in a biotech, pharmaceutical, or CRO/CMO environment with Quality experience. If you fit this description and thrive at problem-solving and possess a keen eye for detail, we'd love to hear from you!

Essential Responsibilities

• Participates in the monitoring of the Quality Management Systems (QMS), including, but not limited to, Vendor Program, Training Program, Facility/Process Inspections, Quality Metrics, or Document Management
• Ensures all Corporate GxP activities related to QMS are in in compliance with national/international GxPs
• Obtains and maintains professional and technical knowledge by attending educational workshops; reviews professional publications and establishes personal networks
• Supports conduct of regulatory inspections and audits (external and internal), by facilitating scheduling and staff coordination, accessing records, addressing inspection/audit requests, and performing other tasks, as required
• Assist with QA oversight over the archive, including, but not limited to ensuring access to the archive is controlled; storing and retrieving records in an orderly manner; properly controlling and documenting records and materials in and out of archive; and maintaining an organized system of indexing records and materials within the archive
• Ensures records are indexed, filed and tracked, and retained in the physical and electronic archives as per the approved procedures
• Conducts all archivist functions in compliance with national/international GxPs

• Bachelor’s degree in biology, chemistry, biochemistry, or other scientific discipline
• Not less than three (3) years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization 

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
• 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.)

• This is a full-time, on-site 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 (10 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.