Quality Assurance Investigations Specialist

Posting Date 2 months ago(8/12/2021 11:03 AM)
Requisition ID
2021-9408
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 Quality Assurance Investigations Specialist at Cook MyoSite will provide oversight of the Investigations & CAPA management system to ensure compliance with requirements, regulations, standards, customer expectations, and business needs, as applicable. Ensure maintenance of inspection-readiness status. Implement continual improvement, assess gaps, and propose meaningful change. Work cross-functionally with relevant departments and responsible personnel to ensure that all deviations are investigated fully, action items are captured correctly and executed in a timely manner, and that all activities are completed, approved, and checked for effectiveness, as appropriate.

Responsibilities

• Develop, implement, sustain, and oversee the Investigations and Corrective Action & Preventive Action (CAPA) program, ensuring compliance with internal and external requirements. Ensure proper systems, processes, procedures, and policies are in place.

• Authors relevant quality system documents. Ensures phase-appropriate compliance. Stays current with agency thinking.

• Drives process improvements to ensure that all deviations / nonconformances are fully investigated and documented, with root cause(s) correctly identified, trends / systemic issues evaluated, and effective CAPAs implemented to prevent recurrence.

• Ensures Investigations & CAPAs are appropriately reviewed and approved prior to execution.

• Facilitate cross-functional involvement in ongoing investigations, and meetings on urgent issues, where needed.

• Ensures proper impact assessment (compliance, product, business) where due dates are extended, or records cancelled.

• Ensures owners of the records provide interim reports / status updates where there are extensions.

• Provides input and reviews, assesses, edits, and approves Investigation and CAPA documentation and related records composed by others, for accuracy and conformance to quality, as well as procedural and regulatory requirements, as applicable.

• Ensures consistent and compliant application of the Investigation & CAPA process across all personnel performing this work.

• This position generally oversees the process but may conduct investigations where they do not perform the review / approval.

• Develops and maintains strong, collaborative partnerships with management and other relevant / responsible personnel to facilitate and manage a strategy that permits the Investigation & CAPA program to scale and align with business drivers.

• Serves as Subject Matter Expert (SME) and stakeholder for Investigation & CAPA activities.

• Interface with department representatives to ensure needed resources are available to complete investigations timely.

• Ensures appropriate escalation to management of critical / significant issues. Communicates with relevant personnel and ensures timely action on Biological Product Deviation Reports, safety issues, market actions, or other reportable events, as required.

• Identifies training opportunities on Investigations & CAPAs. Mentors others on the process, provides necessary tools. Deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc., and create the relevant CAPAs.

• Collaborates with the Training Department to ensure adequate and proficient training on the process.

• Conduct effective interviews of individuals involved in events. Provide training on performing interviews.

• Interfaces with Information Systems as the Process / Business Owner for Investigations & CAPAs in the eQMS.

• Provides data on the management of Investigations & CAPAs, trends, critical issues for Management Review, Strategy meetings, company / department scorecards, internal / external audits, etc. as part of the continual improvement process.

• Provides data on Investigations & CAPAs for Annual Product Review / Product Quality Review, as required.

• Promote and exemplify proper quality culture in a GxP environment.

SME on Investigations & CAPAs for internal / external audits, contributes to the development of responses to observations.

• Perform additional activities related to overall Quality Assurance as requested by management, e.g. audits, vendor qualifications.

Qualifications

• Maintain regular and punctual attendance

• Bachelor's degree or higher, in any life science, biomedical, or related fields

• Minimum of three 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.

• Experience in Quality Assurance and/or Compliance functions and Investigations/CAPAs.

• Must maintain company quality and safety standards

• Ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.

• Ability to work in collaborative and independent work situations and environments with minimal supervision

• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability 

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals

• Trainability

• Must have effective verbal, written and interpersonal skills

• Demonstrates critical thinking and ability to execute goals set by the organization and Department Manager

• Must maintain a high level of confidentiality

• Excellent analytical skills with the ability to analyze situations accurately and effectively

 

Physical Requirements:

• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II area
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time

• Ability to conduct and hear ordinary conversation and telephone communication
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Visual and manual acuity for working with computers and equipment

• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
• Must be able to perform PPE gowning procedures on a frequent basis to enter BioSafety Level II area including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis

• 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
• Travel possible up to 10%

 

 

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