Job#: 3032003

Job Description:

Clinical Quality Assurance (QA) Specialist – Oncology

Our Waltham based client is seeking a detail‑oriented Clinical QA professional to support quality and compliance activities across oncology clinical development programs. This role helps maintain and improve the Clinical Quality Management System (QMS) and ensures clinical trials meet GCP, regulatory, and internal quality expectations. You’ll collaborate closely with Clinical Operations and cross‑functional teams to drive audit readiness, quality oversight, and process improvement in a fast‑paced biotech environment.

Key Responsibilities

• Support QMS maintenance, SOP updates, and regulatory compliance

• Assist with internal and external audits, documentation, and CAPA tracking

• Partner with Clinical Operations on quality oversight and issue resolution

• Support clinical trial documentation, processes, and TMF review

• Contribute to GCP/QA training and maintain systems such as eQMS, CTMS, and eTMF

Qualifications

• Bachelor’s degree in life sciences preferred

• 5+ years in clinical development with ICH guideline familiarity

• Experience with QA, QMS, audits, or SOP development is a plus

• Strong organizational, communication, and problem‑solving skills

• Proficiency in Microsoft Office; familiarity with CTMS, eTMF, or eQMS preferred

Additional Information

• Hybrid role (minimum 2 days onsite in Waltham, MA)

• Flexible hours to support global collaboration

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. 

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.apexsystems.com/privacy-policy

Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

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