Senior Business Process Specialist – Biospecimen

Concord USA • Bay Area, CA

3d • $60 - $75 • Onsite

About The Position

We are seeking an experienced Process & Business Analyst with strong biospecimen management expertise to support the implementation and strategic adoption of a new Biospecimen Acquisition and Management platform across global molecular diagnostics teams. This role requires someone who is comfortable engaging with senior leadership, can operate strategically, and is also able to get hands-on with process design, requirements gathering, documentation, change management, and stakeholder alignment. You will play a critical role in shaping how this new tool is used across the organization and influencing ownership and workflows moving forward. Candidates must have hands-on, inside-the-lab experience.

Requirements

• 5+ years of experience in biospecimen acquisition, biobanking, clinical trial management, interfacing with stakeholders and/or project management.
• Bachelor’s degree in a biological discipline or related field.
• Experience in research, diagnostics, pharmaceutical, CRO or medical device industry.
• Experience in the use of LIMS or other validated systems.
• Experience with GLP/GCP requirements and awareness of the ethical considerations for the use of biological samples
• Self-motivated individual who can maintain quality, accuracy and timeliness of deliverables.
• Strong interpersonal skills and the ability to build effective working relationships inside and outside their functional area
• Ability to work in a fast paced, dynamic environment with efficiency; and capable of handling multiple projects.
• Good organizational, written, and verbal communication skills, including excellent data handling skills, meticulous, proficient with MS Office and Google suite.
• Experience in handling biological specimens & willingness to work with potentially infectious biological material.
• Knowledge and skill in inventory management.
• Must be able to lift 30lbs, work in a cold environment with limited daylight, stand for long periods of time, and climb ladders.

Nice To Haves

• A Master’s degree in a biological discipline is highly desired.
• Prior data management experience in the diagnostics, pharmaceutical or medical device industry preferred.

Responsibilities

• Own end-to-end biospecimen acquisition, data management, and/or biorepository management activities.
• Collaborate across global teams to ensure biological material needs are clearly defined, documented, communicated, and met.
• Work closely with stakeholders including Procurement, Legal, Safety, Quality, and Imports/Exports.
• Participate in internal and external project meetings and provide regular updates.
• Maintain compliance with biospecimen processes and ensure accurate documentation.
• Manage information in validated Laboratory Information Management Systems (LIMS) in alignment with GxP standards.
• Identify and manage project issues, risks, and changing priorities.
• Support audit readiness for Safety, Quality, and Regulatory requirements.
• Leverage scientific expertise to influence decisions affecting project deliverables.
• Provide guidance, mentorship, and training to junior team members.
• Design, plan, and implement moderately complex sample acquisition strategies.
• Develop collection contracts and scopes of work.
• Monitor acquisition progress, resolve discrepancies, and maintain documentation.
• Ensure compliance with GCP, GLP, quality standards, and ethical regulations.
• Manage biospecimen data transfers, entry, review, validation, and consistency checks.
• Work within validated databases ensuring accuracy and adherence to standards.
• Collaborate on data standardization initiatives.
• Act as a power user for key IT systems and support LIMS change cycles.
• Oversee biological material processing, shipment, inventory, discrepancies, and retrievals.
• Lead planning and execution of biorepository projects.
• Ensure compliance with permitting, import/export, and safety requirements.

Benefits

• Health, Dental, and Vision Insurance: Comprehensive coverage to support your overall well-being.
• Employer Contributions to Health Savings Accounts (HSA): For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.
• Flexible Spending Accounts (FSA): Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.
• Disability Insurance: Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.
• Life and AD&D Insurance: Employer-provided coverage with options for additional voluntary coverage.
• Employee Assistance Program (EAP): Support for legal, financial, and personal challenges.
• 401(k) Retirement Savings: 1% employer match.
• Career Growth Opportunities: Pathways for advancement and skill development.
• Team Engagement Activities: Regular team-building events and company-sponsored activities to foster collaboration and connection.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 51-100 employees