Clinical Quality Assurance Specialist II
Location
Marlborough, MA | United States
Job description
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.
Job tags
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