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.

The Archive Manager is responsible for the management, operation, and procedures related to archiving in accordance with BioAgilytix standard operating procedures and relevant GxP regulations. Their responsibilities encompass the strategic management, efficient operation, and meticulous procedural oversight of the archival function, including the seamless integration and oversight of external vendors to optimize the archival process and maintain the highest quality standards.

 

·Reviews archival submissions, both physical and electronic, for completeness and accuracy and ensures these materials are organized, traceable, and maintained properly while archived

·Ensure that the retrieval of records/materials will be facilitated by a system of indexing to ensure that the movement of records and

materials in and out of the archive is properly controlled and documented

ensure strict adherence to BioAgilytix’s standard operating procedures.

· Stay updated on and enforce pertinent GxP regulations related to archiving

·Implement best practices to enhance the productivity of archival activities

·Oversee the creation, maintenance, and adherence to archiving procedures and protocols

·Participate in regular Sponsor audits to retrieve the appropriate documents, explain the archive procedures, and verify compliance with established procedures

·Establish processes and procedures for managing external vendors for archiving services and document flow of outgoing and incoming archived data to external vendor

·Collaborate with vendors to ensure seamless integration and efficient management of archival activities

·Collaborates and communicates with the off-site archival storage facility to ensure safety and accessibility of off-site materials

·Maintain the highest quality standards in archiving, including data integrity and preservation

·Implement quality measures to safeguard archived materials

·Maintain comprehensive records of all archival activities

·Ensure accurate and complete documentation of archived materials

·Identify potential risks and develop mitigation strategies to protect archived data and materials

·Be fluent with all electronic data systems to ensure appropriate archival

·Implement disaster recovery and contingency plans

·Communicate archiving updates and issues to relevant stakeholders

·Generate regular reports on archiving performance and compliance

·Develop and manage budgets for archiving activities, including vendor contracts and equipment procurement

·Ensure seamless data transfer and integration between different systems `

·Conduct regular reviews and assessments to drive ongoing enhancements

·Supervises any assistant archivist or archival interns in their duties as archival personnel

·Obtains and maintains professional and technical knowledge by attending educational workshops and conferences, reviewing professional publications, establishing personal networks, etc.

·May be the primary contact for alarm notifications by the electronic monitoring system specifically for the archive room

·Scan and post Archive Employee Signature pages, document date of termination, and archive when appropriate

·Move Reagent Preparation electronic scans to appropriate folders on a regular basis. Supply labs with binders for hard-copy Reagent Preparation storage.

·Document and archive dispositioned data

·Possibly commute between sites depending on the hiring location

·Other duties as needed

·Master’s degree in archival studies or similar with two or more years of experience in archival or administrative positions

·Versatility, flexibility, and willingness to work within constantly changing priorities; ability to manage and complete multiple projects in a timely manner

·Strong leadership, collaboration, and influencing skills; demonstrated ability to problem solve and drive positive change

·Ability to deal effectively with a diversity of individuals at all organizational levels

·Excellent interpersonal, oral, and written communication skills; ability to successfully interact with key internal stakeholders and vendors

·High level of proficiency in Microsoft Office (Word, Excel, and Outlook)

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

 

·Driver’s License 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.