Archivist at BioAgilytix

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor’s degree in library science or a scientific field
Minimum of two (2) years of experience as an archivist or in an administrative position
Previous experience working in GxP environment is preferred
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
Ability to work independently with little supervision for completion of daily tasks
Acute attention to detail and organizational skills
Excellent oral and written communication skills

Responsibilities

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
Participate in regular Sponsor audits to retrieve the appropriate documents, explain the archive procedures, and verify site compliance
Responsible 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 regulations
Collaborate with vendors to ensure seamless management of off-site archival activities
Ensuring 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 documented
Maintain archived copy of master schedule and comprehensive record of all archived materials
Be fluent with site specific electronic data systems to ensure appropriate archival of electronic study files
Communicate archiving updates and train site personnel on changes to archival procedures
Generate scans of study records and certified scans as required by sponsor contracts
Coordinate and oversee disposition and destruction of records that have met or exceeded their required retention periods
Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
Other duties as needed

Skills

Archiving

Record Management

GxP Regulations

Indexing

Data Management

SOP Adherence

Auditing

Problem-solving

BioAgilytix

Bioanalytical testing for drug development

About BioAgilytix

BioAgilytix offers specialized bioanalytical testing services for the pharmaceutical, biotechnology, and agricultural biotechnology industries, focusing on large molecule studies essential for drug development. They provide various assays, including pharmacokinetics, pharmacodynamics, cell-based, and immunogenicity assays, to measure drug effects and safety. With a global presence, particularly in Europe, BioAgilytix distinguishes itself by its comprehensive testing services tailored to the needs of life sciences companies. Their goal is to support the development and validation of new treatments while ensuring the safety and efficacy of agricultural products.

Durham, North CarolinaHeadquarters

2008Year Founded

$29.3MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Company Match

Parental Leave

Employee Referral Bonus

Risks

Cancellation of Durham expansion may impact growth and local economic contributions.

Regulatory challenges may arise in US market for Stockholm3 prostate cancer test.

Hamburg lab expansion may strain resources, affecting service quality.

Differentiation

Specializes in immunoassays and cell-based assays for large molecule studies.

Operates globally with significant presence in Europe and the US.

Offers comprehensive suite of assays including PK, PD, and immunogenicity.

Upsides

Increased demand for personalized medicine boosts need for specialized testing services.

Growing market for biosimilars and biobetters expands client base opportunities.

Global cell-based assay market growth aligns with BioAgilytix's expertise.

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