Job Description

Quality Assurance Specialist II at Boiron USA

5 days in office Schedule

Must be able to commute to Newtown Square, PA

What does Boiron Do?

For over 85 years, Boiron has been dedicated to providing families with the purest medicines made from the earth's best resources. As a leader in the natural health and wellness space, Boiron offers solutions for common ailments such as cold, allergies, heartburn, muscle soreness and many more. You can find Boiron products in top retailers nationwide.

What would you be doing as a Quality Assurance Specialist II?

The QA Specialist II must oversee and maintain compliance/regulatory activities as well as day-to-day Quality functions in support of overall quality systems and domestic packaging operations. The candidate must be versatile, independent, an effective communicator and must have strong leadership skills. This individual will utilize QA experience to provide support to Quality Assurance leadership. 

But what does this role really do?

• Development, review and approval of product specifications.
• Development, review and approval of Master Batch Records.
• Review and release of finished product packaged domestically.
• Support Quality Assurance Manager in qualification and evaluation of vendors.
• Initiation and follow-through for controlled document Change Controls.
• Participation in development and review of facility qualification and maintenance documents.
• Participation in development and review of equipment qualification and maintenance documents.
• Participation in IT validation projects.
• Procedure development, update, distribution and implementation.
• Training of personnel in procedures and development of training programs in support of the Quality Assurance Manager.
• Initiation of investigations and deviations, root cause analysis, recommend and implement CAPA.
• Record, review, report, investigate, and file product quality complaints.
• Collaborate with Boiron S.A. counterparts in France.
• Conduct internal audits, identify non-conformances, recommend and implement CAPA.
• Conduct vendor audits as requested.
• Support third party audit programs.
• Actively support regulatory inspections.
• Inspect and process product returns as requested.
• Inspection of product in support of investigations as requested.
• QA Documentation retention, filing and maintenance.
• Maintain open communication with branch teams and vendors to resolve challenges.
• All other duties as assigned.

You would be a great fit if you have the following...

• Education: Bachelor's degree in Life Science or related field or equivalent experience.
• Minimum of (4) four years’ experience in QA/QC with FDA regulations and pharmaceutical cGMPs.
• Knowledge of Microsoft Office software with ability to use Word and Excel spreadsheets with graphing.
• Demonstrate meticulous attention to detail in following procedures, preparing written documentation, and completing QA/QC activities.
• Work independently at a high level and enforce compliance goals and requirements.
• Ability to work in a high paced, multi-tasked environment.
• Have a strong affinity for teamwork.
• Self-starter that is hard working with interpersonal and communication skills.
• Strong organizational and technical skills.
• Ability to travel 10% domestic primarily; this may include overnight and/or weekend travel.

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