Quality Assurance Analyst, Sr. - Healthcare jobs in San Diego, CA

Who Are We?

Founded in 1997 and built upon 26 years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Sr. Quality Assurance Specialist?

Your Main Responsibilities and Duties Include:

• Assist in the maintenance of an effective Quality Management System to ensure the company’s compliance with all relevant regulatory requirements and company SOPs.
• Assist in the conduct of various client audits, database audits, TMF audits, and review of clinical study reports.
• Assist in the development, maintenance and management of the company’s policies, SOPs and associated processes and procedures.
• Track metrics for QA activities and audit observations that will form the basis for continuous improvement practices and processes. Participate in the management of the company’s SOP deviation and CAPA systems.
• Maintain records of employee training on policies, SOPs, and associated processes and procedures using TI’s Learning Management System (Compliance Wire).
• Support development of strategies for various QA projects and programs.
• Work with the QA Department head and various other department heads to identify, improve, and/or resolve quality-related issues as identified via audit findings, SOP reviews, rework, etc.
• Provide support to the QA Department as requested by the department head and management.
• Serve as Quality Assurance head backup as needed to support Quality department day to day functions and activities
• Develop a mindset of needing continuous training (SOPS, FDA regulations, ICH guidelines, industry seminars, etc.) to better serve the company in this role.

To Succeed in this Position:

• Ideally, you will have a Bachelor’s degree with at least three (3) years of experience in GxP Quality Assurance. If you do not possess a Bachelor’s degree,  you should have five to seven (5-7) years of applicable GxP QA experience. QA systems compliance within a GCP environment is preferred.
• You should possess a strong knowledge of Good Documentation Practices and Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
• You should have some GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is plus.  Attention to detail as well as a clear and concise style in written and oral communications is required. Previous experience in electronic Quality Management Systems (eQMS) a plus.

 ** Please note that this is a hybrid position that is currently required to be onsite three days a week.

The most likely starting base pay range for this position is $70,000 - $75,000 per year. Several factors, such as experience, tenure, skills,  and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. If you are smart and good at what you do, we welcome you to apply!