Quality Assurance Associate I
About The Position
The Quality Assurance Associate I performs detailed quality reviews of batch records and associated records for final dispositioning and ensuring compliance with procedural and regulatory requirements. Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, 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.
Requirements
- Undergraduate degree in any Life Sciences and 1-3 years’ relevant experience or 6 years direct, relevant experience in Quality Assurance to provide a comparable background
- Minimum of 3 years' experience in Quality Assurance
- Proficient knowledge of Microsoft Office software, and other general office equipment.
- Knowledge of cGMP regulations and good documentation practices
Responsibilities
- Review and approve documentation associated with incoming biopsies.
- Review and approve documentation associated with incoming materials
- Review and approve records and associated data in support of cGMP operation activities.
- Create batch records, product labels and performs label verification processes.
- Perform quality reviews and approvals of batch records. Responsible for dispositioning batches.
- Participate in company projects as a quality representative.
- Participate in risk assessment activities.
- Perform investigation report writing, reviewing and closing investigation reports.
- Conduct and document training events.
- Management of customer complaints.
- Authoring quality system documents.
- Perform various office-related duties; filing, scanning, and data entry.
- Promote GLP/cGMP environment and follows procedural guidelines.
- Exemplifies Cook MyoSite Core Values
- Maintain regular and punctual attendance
- Must maintain company quality and safety standards
- This position requires an 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
- Able to prioritize and operate proactively
- Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management
- Must maintain a high level of confidentiality
- Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations
- Demonstrates critical thinking and ability to execute goals set by the organization and Department Manager
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
