Clinical Quality Assurance Specialist II

Recruiter: Spencer Gregory Hale

 

Clinical Quality Assurance Specialist II

 

About the role:
Seeking a Clinical Quality Assurance Specialist to assist with Clinical QA activities, for the Peripheral Interventions Pharmaceutical business at Boston Scientific. This role serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
 

Key responsibilities include:

• Maintain Clinical Pharmaceutical Quality System (PQS) in accordance with regulatory requirements and industry best practices.
• Ensure that all Clinical PQS controlled documents, such as Standard Operating Procedures (SOPs), work instructions, forms, and templates, are properly managed and maintained.
• Collaborate with cross-functional teams to ensure that documents are accurate, up-to-date, and accessible to relevant personnel.
• Conduct periodic reviews and audits of controlled documents to identify and address any gaps or non-compliance issues.
• Coordinate and support document control processes and requirements.
• Assist in the preparation and execution of regulatory inspections and audits related to document control.
• Continuously monitor industry trends and regulatory updates to ensure compliance with evolving requirements.
• Identify opportunities for clinical QA process improvement and implement initiatives to enhance document control efficiency and effectiveness.
• Coordinate or assist management of Clinical Deviations, Quality Events and/or CAPAs.
• Perform vendor assessment or other internal clinical audits as necessary.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Pharmaceutical Quality System compliance and adherence to the BSC Quality Policy.

 

What we're looking for in you:
Minimum requirements

• Associate degree with minimum 5 years of experience or bachelor’s degree in a scientific or related field with 2 years of experience in pharmaceutical quality assurance, with a focus on clinical QA or clinical.
• Strong knowledge of regulatory requirements and industry standards related to document control in the pharmaceutical industry (e.g., FDA 21 CFR Part 312, GMP, ICH E6). 
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Ability to work independently and prioritize tasks in a fast-paced environment.

 

Preferred qualifications:

• Experience in developing and implementing clinical and Clinical QA procedures.
• Proficiency in using electronic document management systems such as Master Control
• Excellent attention to detail and organizational skills.

 

Requisition ID: 577706

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

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