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Apogee Therapeutics · 3 hours ago

QA Document Control Specialist

United States

Full-time

Remote

Mid Level

$85K/yr - $100K/yr

3+ years exp

Apogee Therapeutics, Inc. is a biotechnology company focused on developing biologics for treating inflammatory diseases. They are seeking a Document Control Specialist to manage document control activities within their electronic document management system, ensuring compliance with GXP regulations and supporting cross-functional teams in maintaining document accuracy and integrity.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Maintain document control policies, procedures, and systems in accordance with GXP regulations

Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training

Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records

Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.”

Maintain robust quality control measures for all GXP documents

Leverage experience with Veeva Systems to optimize document management processes and workflows

Provide guidance and training to staff on using Veeva for document control and compliance purposes

Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH)

Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance

Identify opportunities for improvements in GXP document and record control practices

Qualification

Veeva Quality VaultGXP regulationsQuality Assurance experienceDocument controlComputer System ValidationMicrosoft OfficeAdobe AcrobatSmartsheetAttention to detailCommunication skillsProblem-solving skillsCross-functional collaborationGrowth mindset

Required

Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences)

Minimum of 3-5 years' Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry, with 1-2 years' direct experience within Veeva Quality Vault

Working knowledge of electronic document management systems; Veeva Quality Vault required

General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems

Strong attention to detail and a commitment to maintaining accuracy and compliance required

Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet

Exceptional organizational, communication, and problem-solving skills

Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects

Ability to collaborate and work effectively with cross-functional teams

Familiarity of GXP regulatory requirements and quality standards

Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment

Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless

Ability and willingness to travel up to 10% (approximately 3-6 times per year for company meetings)

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

Commitment to growing you professionally and providing access to resources to further your development

Apogee offers regular all team, in-person meetings to build relationships and problem solve

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)