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 Archivist 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 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.
Essential Responsibilities Reviews archival submissions, both physical and electronic, for completeness and accuracy andensures these materials are organized, traceable, and maintained properly while archivedEnsure that the retrieval of records/materials will be facilitated by a system of indexing toensure that the movement of records and materials in and out of the archive is properlycontrolled and documented. Ensure strict adherence to BioAgilytix’s standard operating proceduresParticipate in regular Sponsor audits to retrieve the appropriate documents, explain the archive procedures, and verify site complianceResponsible for the management, operation and procedures for archiving (hard-copy and electronic) and retention policy in accordance with BioAgilytix standard operating procedures and current relevant GxP regulationsCollaborate with vendors to ensure seamless management of off-site archival activitiesEnsuring that access to the archive (electronic and hard copy) is controlled, environmental monitoring is performed for the archive, all records are orderly stored and 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 documentedMaintain archived copy of master schedule and comprehensive record of all archived materialsBe fluent with site specific electronic data systems to ensure appropriate archival of electronic study filesCommunicate archiving updates and train site personnel on changes to archival proceduresGenerate scans of study records and certified scans as required by sponsor contractsCoordinate and oversee disposition and destruction of records that have met or exceeded their required retention periodsObtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks.This function may be in combination with another QA function (job description) Additional Responsibilities Other duties as needed Minimum Preferred Qualifications: Education/Experience Bachelor’s degree in library science or a scientific field A minimum of two (2) years of experience as an archivist or in an administrative positionPrevious experience working in GxP environment is preferred Minimum Preferred Qualifications: Skills Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely mannerAbility to take direction well and multi-taskAbility to work independently with little supervision for completion of daily tasksAcute attention to detail and organizational skillsExcellent oral and written communication skills Supervisory Responsibility This position has no supervisory responsibilities Supervision Received Frequent supervision and instructionsInfrequently exercises discretionary authority Working Environment Primarily officeRoutinely 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 dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent bending and twisting of upper body and neckLight to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 poundsAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendance Position Type and Expected Hours of Work This is a full-time positionSome flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee HandbookOccasional weekend, holiday, and evening work required Additional Information 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.
Compensation The hourly pay range listed above reflects BioAgilytix’s hiring range for this position.
