Quality Assurance Specialist

Company: Actalent
Location: Camarillo
Posted on: September 17, 2022

Job Description:

Single-use manufacturer that supports the biotech industry looking for a QA specialist to join their team in Camarillo! *root cause analysis required***ISO 9001** Position starting off as hybrid! Description:The Quality Assurance Specialist I will collaborate with stakeholders to develop, implement, and maintain the Quality Management System and its platform. The QA Specialist I will execute risk assessments, develop testing methods and various quality assurance requirements. In addition, this position will provide regulatory and technical support for programs that oversee product specifications/requirements. The role will be responsible for the maintenance and implementation of corrective actions, validations, and technical documents.Primary Responsibilities: --- Initiate, execute and complete investigations associated with material/product specifications.--- Evaluate material/ product non-conformances to identify and assess root cause.--- Interface with impacted departments to identify and evaluate risk associated with product impact. --- Provide support for all aspects of testing related to material specifications.--- Lead groups to ensure investigations and resolutions related to quality and product are completed.--- Effectively communicate, lead and support inspectors and production personnel as initial technical support contact.--- Participate in meetings/projects as required (safety, problem solving, team meetings).--- Participate in process improvement teams and/or completes relative documentation when required.--- Support quality manager in suggesting or communicating ideas for continuous improvement to maximize product quality and minimize costs. --- Prepare and submit reports to the quality manager or supervisor.--- Support compliance with established practices, polices, to meet customer/contractual obligations and in compliance with regulatory codes and standards. --- Comply with all safety requirements ensuring work areas meet standards.--- Responsible for facilitation of document control and training programs.--- Lead the management of risk assessments that pertain to or impact material and/or regulatory requirements.Preferred Experience--- General understanding of global pharmaceutical product regulations with experience with ISO 9001 and/or 21 CFR Parts 210 and 211--- Minimum of 2 - 4 years' experience with technical documentation for quality activities, such as corrective actions quality audits, and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.--- Solid organizational and planning skills.--- Be self-motivated, attentive to details and able to prioritize and meet deadlines.--- Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.--- Must be able to work effectively and lead others efficiently in a team environment.--- Basic statistical mathematical and computer skills including the ability to trend data.--- Basic project management skills--- Independently understand, follow, and implement instructions.Skills:root cause analysis, quality assurance, method development, GMP, documentation, deviation, document control, 21 CFR part 210, 21 CFR part 211, USP class 6, technical writing, ISO 9001, ISO 13485, CAPA, drug manufacturingExperience Level:Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Camarillo , Quality Assurance Specialist, Other , Camarillo, California