QA Document Control and Training Associate/Manager

Title: Quality Assurance (QA) Document Control/Training Associate/Manager

Report: Head of QA

Location: Philadelphia, PA

Position Type: Full Time, Exempt

Travel: up to 10%

Company Summary

VintaBio is a technology company focused on simplifying viral vector production. Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. Our research core produces high-yield and world-class POC vectors. Through a comprehensive production workflow that utilizes VintaBio's proprietary cell lines and transfection reagents, we expedite the path to the clinic, offer more reliable manufacturing, and improve economics.

Position Summary

The role of the QA Document Control/Training Manager is to oversee document control and training activities to support non-GMP and GMP operations and maintain compliance with health authority regulations and established VintaBio standards.

Key Responsibilities

• Lead day-to-day Document Control activities including creating, revising, reviewing, tracking and releasing Standard Operating Procedures (SOP), Batch Production Records (BPRs), Work Instructions (WI), and other controlled documents in a timely manner while ensuring compliance with all Quality, Regulatory and company standards.
• Print, compile and issue all lot related documentation (batch records, forms, sample plans, specifications, etc.).
• Serve as point-person/system admin for the company's electronic Quality Management Systems (eQMS).
• Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
• Establish and maintain records management system including secure storage, retrieval, retention and destruction.
• Identify and implement document control process improvements to ensure compliance with internal and regulatory requirements.
• Participate in the implementation and periodic maintenance and upgrades to the eQMS, including creating/revising procedures and performing validation activities.
• Provide support during regulatory/client inspections as well as internal audits.
• Provide support to companywide users and training of new hires and partners in Document Control processes.
• Track KPIs/metrics and report progress during Quality Management Reviews.
• Executes GMP Training strategy – including working with stakeholders to determine learning needs and priorities and provides appropriate training to meet those learning needs.
• Evaluate training needs and participate in the development and delivery of training materials, for network initiatives, including but not limited to Quality and GMP functions as needed, utilizing high-quality, innovative, timely, and effective learning solutions.
• Maintain and improve onboarding experience in alignment with company deliverables.
• Develop training materials (ex: eLearnings, Instructor led), in collaboration with SMEs, for existing employees ensuring all aspects of job responsibilities and expectations are met to improve efficiency, effectiveness and compliance and address gaps appropriately.
• Provide guidance and information to leadership on recommended training programs, curricula and training material development, and learning assignments.
• Manage projects and training initiatives which directly support non-GMP and GMP initiatives, to effectively implement strategic business objectives in driving quality, compliance and safety.
• Support policy and procedural changes and manual design to improve the quality of the department, to include scheduled reviews of all existing documentation, guidelines and materials. Evaluate and report on effectiveness of the changes.
• Works as a training and competency expert with various teams and clients developing training material via eLearning, video, and other presentations.

Education and Experience

• Education: Bachelor’s Degree (preferably in a science related discipline) required.
• Minimum 3 years (Associate) or 5 years (Manager) in a pharmaceutical biotechnology environment, preferably in a Quality Assurance role supporting compliance programs and systems.
• CDMO or CRO experience a plus.
• Prior experience working with Veeva is preferred.
• Experience developing, implementing, and maintaining quality systems and procedures.

Knowledge, Skills and Abilities

• Ability to interpret and apply current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable regulations and standards.

• Must be proficient in Microsoft Office products.
• Attention to detail and quality are critical to success.
• Excellent organization and multi-tasking skills.
• Ability to manage and prioritize projects under tight deadlines.

• Ability to work independently with minimal daily instruction.
• Ability to think strategically to improve current processes.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas.

Physical Requirements

• Ability to lift and carry up to 15lbs
• Ability to push or pull up to 25lbs
• Ability to sit, stand, and walk for extended periods
• Ability to bend, squat, kneel, and reach.

Other Physical Requirements:

• Must wear appropriate gowning and Personal Protective Equipment (PPE) when entering into Cleanroom and Laboratory areas.

Work Environment: Work is performed primarily in the office. This noise level in the work environment is usually quiet in typical settings and moderate in other situations.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this position description and/or assign tasks for the employee to perform, as the Company may deem appropriate.