Job Description

POSITION SUMMARY

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.

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.

 PREFERRED SKILLS:

EDUCATION/TRAINING: Bachelor’s degree in a technical or scientific skill desired, or High School Diploma with equivalent with 1-2 years of experience in quality assurance functions, including Root Cause Analysis, Corrective Actions, Effectiveness Checks/Verifications.