Quality Assurance Change Control Specialist

Posting Date 1 month ago(8/16/2021 4:24 PM)
Requisition ID
2021-9424
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The QA Change Control Specialist at Cook MyoSite provides oversight of the change management system to ensure compliance with requirements, regulations, standards, customer expectations, and business needs, as applicable. Ensures the change management system is maintained in a state of inspection readiness. Assesses gaps and propose improvements. Interfaces with Document Control personnel on document changes. Works cross-functionally with QA Functional Area Specialists, relevant departments, and responsible personnel to ensure that all actions are captured in Change Controls (CCs) correctly and are executed correctly in a timely manner.

Responsibilities

• Develops, implements, sustains, and oversees the Change Control (CC) program, ensuring compliance with internal and external requirements. Authors quality system documents.
• Ensures proper systems, processes, procedures, and policies are in place for the management of effective change.
• Maintains effective and compliant CC process in the electronic Document Management System (eDMS).
• Assists with process improvements to the current system for implementation, and proper execution of CC practices.
• Ensures relevant activities are performed under CC, as required.

• Ensures completion and monitoring of effective activities.
• Ensures CC are appropriately reviewed and approved prior to execution.
• Ensures consistent and compliant application of the CC process across all QA Functional Area Specialists.
• Provides input and reviews, assesses, edits, and approves CC documentation and related records composed by others to ensure accuracy and conformance to quality as well as procedural and regulatory requirements, as applicable.
• Ensures that CAPAs are documented properly and implemented.
• Ensures that all CCs have comprehensive rationale, impact assessment, and implementation plans with follow-up actions documented.
• Ensures that all approved actions are implemented per commitment.
• Follows-up with CC and CAPA owners to ensure timely implementation.
• Develops and maintains strong, collaborative partnerships with management and other relevant / responsible personnel to facilitate and manage a strategy that permits the CC program to scale and align with business drivers.
• Serves as SME and stakeholder for CC activities supporting manufacturing operations, projects, and contract work, as applicable, providing proper QA oversight and involvement, where needed.
• Ensures Regulatory Affairs, Validation, and other departments are involved in the CC process, as needed.
• Interfaces with Quality Compliance, Quality Control, Supply Chain, and others on changes in regulations, guidance, standards, materials, compendia, etc., as needed.
• Identifies training and coaching opportunities on CC within the company.

• Mentors and trains others on CC tools and processes.

• Collaborates with the Training Department to ensure adequate and proficient training on the CC process.
• Ensures proper assessment of impact on product where change implementation was postponed or cancelled.
• Provides support and serves as backup, to the QA Specialist and others in Document Control, as well as the QA Specialists in the Functional Areas managing change for those respective departments. Collaborates with Doc Control on changes to documents.
• Interfaces with Information Systems in the role of Process / Business Owner for CC in the eQMS.

• Provides input on the establishment of computerized systems used for management of change.
• Responsible for developing and maintaining data collection and generation systems, tracking tools and reporting mechanisms.
• Provides data on the management of CC for Management Review, Monthly Strategy Meetings, strategic and department scorecards, internal audits, and other efforts, as part of the continual improvement process and assessment of the health of the quality system (QS).

• Provides data on changes for inclusion in Annual Product Review reports for commercial products.
• Performs data analysis to identify patterns, trends, or systemic issues so problems in the CC system can be addressed.
• Promotes and exemplifies quality culture and GxP environment.
• SME on CC for internal and external audits and contributes to the development of responses to observations.

Qualifications

• Undergraduate degree in any life science, related engineering field and 3 years’ experience in pharmaceutical/biopharmaceutical industry or 6 years direct, relevant experience in pharmaceutical/biopharmaceutical quality assurance to provide a comparable background

• Minimum of 3 years' experience in applying GMP requirements and sufficient biology/biochemistry to understand the methodology associated with manufacturing a cell therapy product in an FDA-regulated environment is preferred

• Experience in Quality Assurance and/or Compliance functions and CC processes is preferred

• Basic understanding of cGMP and regulations associated with Bio/Pharmaceutical product manufacturing
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Ability to learn and support new systems and applications, and the ability to provide technical training to end users

• Experience with eQMS, eDMS, and continual improvement methodologies
• Knowledge of current Good Manufacturing Practices (GMPs), FDA and European regulations, familiarity with ICH guidelines and World Health Organization
• Experience with regulatory agency audits / inspections
• Good verbal, written, and interpersonal communication and interpersonal skills
• Application competency, including Microsoft Word, Excel, PowerPoint, Visio, and Outlook. Adobe,
• Excellent organizational skills, and attention to detail.
• Listening skills to understand concerns, reasoning to be responsive, and build strategic relationships.
• Demonstrated ability to perform work independently
• Ability to work in a fast-paced environment of shifting priorities
• Aptitude to comprehend, analyze, and interpret process and systems information, technical procedures, reports, and regulations to make correct decisions in a GMP environment
• Proven track record of establishing and maintaining effective working relationships with managers and employees, as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan.
• Experience with MasterControl

 

Physical Requirements:

• Laboratory Setting (Non-Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

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