Sr. Associate, Quality Operations

PURPOSE

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Ensure that all products manufactured at the site are produced, tested and released in compliance with SOP’s, cGMP’s, FDA and EU requirements.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve Master Batch Records (MBR’s) and executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Provides site GMP and GDP training (annually, for new hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as minor and major Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products
• Generate, review and approve Media Fill Protocols and summary reports, as well as participate as a Quality observer as needed.
• Perform and assist with Quality Oversight for Manufacturing, QC and warehouse.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas.
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Lead and perform site internal audits.
• Lead and/or support customer audits, audit readiness and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
Bachelor’s degree in science or related field	Essential
Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials	Essential
Familiarity of eQMS systems such as Veeva	Desired
Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms	Desired
Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms	Desired
ON-THE-JOB EXPERIENCE
6+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role	Essential
Leadership or Mentoring Responsibilities	Desired
Experience working in with early phase clinical trial production and testing	Desired
Previous experience with a startup CDMO and/or in the field of Gene Therapy	Desired
SKILLS / ABILITIES
Manage multiple projects, set priorities, and work in fast-paced, ever-changing environment	Essential
Communicate confidently and effectively with management, peers and key stakeholders	Essential
Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving	Essential
Work independently and be self-motivated	Essential
Proven ability to work cross-functionally to achieve business outcomes	Essential

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Vision

• Frequently utilize close vision and the ability to adjust focus
• 20/20 or Corrected 20/20 Vision

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail