Technical Documentation Specialist, Batch Record Review

1. Technical Documentation Specialist

Position Summary

The Technical Documentation Specialist provides professional expertise supporting the organization's business objectives. The role partners with cross-functional stakeholders to deliver high-quality work, apply functional best practices, and drive operational excellence within the assigned area.

Key Responsibilities

• Execute responsibilities aligned with the functional discipline and business priorities.

• Partner with internal stakeholders to plan, coordinate, and deliver work products.

• Analyze information and recommend practical solutions.

• Maintain documentation, reporting, and compliance with applicable policies.

• Identify opportunities for continuous improvement.

• Communicate project status, risks, and issues proactively.

Required Qualifications

• Relevant experience in this functional area.

• Excellent communication and stakeholder management skills.

• Strong analytical and organizational abilities.

• Ability to manage multiple priorities independently.

Preferred Qualifications

• Life sciences, biotechnology, or pharmaceutical industry experience, where applicable.

• Experience with enterprise business systems and modern collaboration tools.

Technical Skills

• Demonstrated proficiency with technologies commonly used within the Technical Documentation Specialist discipline.

• Microsoft 365 proficiency.

Core Competencies

Collaboration | Accountability | Critical Thinking | Customer Focus | Continuous Improvement

Batch Record Review

view of executed batch records for commercial drug substance production.

Position Summary

The Batch Record Review role provides professional expertise supporting the organization's business objectives. The position partners with cross-functional stakeholders to deliver high-quality work, apply functional best practices, and drive operational excellence within the assigned area.

Key Responsibilities

• Execute responsibilities aligned with the functional discipline and business priorities.

• Partner with internal stakeholders to plan, coordinate, and deliver work products.

• Analyze information and recommend practical solutions.

• Maintain documentation, reporting, and compliance with applicable policies.

• Identify opportunities for continuous improvement.

• Communicate project status, risks, and issues proactively.

Required Qualifications

• Minimum 5 years of relevant experience in this functional area.

• Manufacturing experience.

• Bachelor's degree in a relevant field.

• Excellent communication and stakeholder management skills.

• Strong analytical and organizational abilities.

• Ability to manage multiple priorities independently.

Preferred Qualifications

• Life sciences, biotechnology, or pharmaceutical industry experience, where applicable.

• Experience with enterprise business systems and modern collaboration tools.

• Bachelor's degree in Chemistry or Chemical Engineering.

Required Technical Skills

• Demonstrated proficiency with technologies commonly used within the Batch Record Review discipline.

• Microsoft 365 proficiency.

Core Competencies

Collaboration | Accountability | Critical Thinking | Customer Focus | Continuous Improvement

Responsibilities

• Prepare, review, process, and administer a variety of agreements, including confidentiality agreements, consulting agreements, vendor and service agreements, statements of work, master service agreements, and amendments.
• Coordinate contract routing, review, and approval workflows with internal stakeholders.
• Support contract execution activities and ensure all required documentation is complete and properly maintained.
• Maintain contract records, templates, amendments, renewals, and related documentation within the contract lifecycle management system.
• Monitor contract status, key dates, expiration timelines, and deliverables.
• Assist internal stakeholders with contract-related questions, documentation requests, and process guidance.
• Ensure contracts comply with company policies, procedures, and approval requirements.
• Escalate contractual issues or non-standard terms to Legal or management as appropriate.
• Assist with maintaining standard templates, clause libraries, and contract administration procedures.
• Support audits, inspections, and compliance-related activities involving contract documentation.
• Prepare reports and maintain accurate contract metrics and tracking information.
• Maintain confidentiality and handle sensitive information with professionalism and discretion.

Qualifications
Education and Experience

• Bachelor s degree required; paralegal certification preferred.
• Minimum of 3 5 years of experience in contract administration, procurement operations, legal operations, or related function, preferably within the biotechnology, pharmaceutical, healthcare, or life sciences industry.
• Experience supporting regulated environments preferred.

Knowledge, Skills, and Abilities

• Basic understanding of commercial contracting principles and contract terminology.
• Strong organizational and time management skills with the ability to manage multiple priorities.
• Excellent attention to detail and accuracy.
• Strong written and verbal communication skills.
• Ability to work collaboratively across functions and interact effectively with internal stakeholders.
• Familiarity with contract lifecycle management systems and document management platforms preferred.
• Proficiency in Microsoft Office Suite and related business systems.
• Strong problem-solving skills and ability to exercise sound judgment.
• Ability to maintain confidentiality and professionalism in handling sensitive information.

Competencies

• Collaboration and teamwork
• Attention to detail
• Organizational and administrative excellence
• Effective communication skills
• Accountability and reliability
• Adaptability and flexibility
• Customer-service orientation

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.