Quality Operations Specialist

7 days ago

Boston, United States Digital Prospectors Full time

Position: Quality Operations Specialist
Location: Boston, MA (Hybrid – 3 days onsite)
Length: 2+ years

Job Description:
Our client is seeking a detail-oriented and independent Quality Operations Specialist to join a dynamic team supporting the Quality Assurance (QA) function for commercial product stability programs. In this role, you will provide QA analytical support, ensuring compliance and quality standards are maintained across various stages of product stability. You will work closely with internal teams and external partners to resolve quality issues, conduct investigations, and support continuous improvement initiatives in a fast-paced and collaborative environment.

Essential Duties and Responsibilities (but not limited to):

Provide quality assurance support for commercial product stability programs, ensuring compliance with regulatory standards.
Collaborate with internal teams and external partners to address quality issues and implement compliant solutions.
Contribute technical expertise to cross-functional teams, supporting investigations and decision-making on quality matters.
Oversee and assist with Root Cause Analysis (RCA) and corrective action plans (CAPA) for product deviations and quality investigations.
Support change control activities related to product stability, from assessment to implementation and closure.
Review and approve GMP documentation, including procedures, specifications, and reports.
Participate in stability program management, ensuring alignment with internal and external protocols and standards.
Ensure compliance with agreements and processes involving third-party manufacturers and suppliers for stability-related activities.
Drive continuous improvement initiatives and assist with risk identification and mitigation planning.

Qualifications:

Bachelor's degree in a scientific field with relevant experience, or equivalent combination of education and professional background.
Strong understanding of regulatory standards and industry practices in a pharmaceutical environment.
Familiarity with analytical techniques commonly used in quality assurance, such as HPLC, dissolution, and related methods.
Experience working with external partners, including manufacturers and testing organizations, to ensure compliance.
Ability to manage multiple projects efficiently in a fast-paced, deadline-driven setting.
Excellent communication skills, with the ability to collaborate across teams and provide clear, concise updates.
Independent decision-making capabilities, with a strong focus on quality and technical expertise.
Experience in quality investigations, corrective action planning, and change control processes.
Proficiency in using electronic document management systems and supporting quality systems.
Advanced understanding of regulatory guidelines and their application in the pharmaceutical industry is preferred.
Experience in operational quality assurance within analytical or manufacturing environments is a plus.
Familiarity with quality improvement methodologies, technical writing, and problem-solving in regulated settings is a plus.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

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Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

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