Clinical QA Specialist
333 W. San Carlos Street, Suite 800 San Jose, CA 95110
Bayside Solutions is seeking a Clinical QA Specialist to be part of our Client’ s team in the South Bay.
Our Client’ s culture is founded on core values that keep them committed to being a collaborative, innovative, honest, and adaptable place to work. They have built a family within the workplace, promote employees from within, provide opportunities for professional development, and encourage their employees to be active in their efforts to impact their surrounding communities.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical QA Specialist
- An opportunity to join an organization focused on the movement of new drugs or devices from conception to FDA approval.
- Work for a company that is local to the beautiful south bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, vacation/PTO, and 401K.
Summary of Responsibilities:
- Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.
- Facilitates and conducts internal and external audits and provides metrics and analysis of trends based on audit findings.
- Assist in the conduct or arrangement of GCP training for all staff.
- Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems.
- Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs and trackers.
- Responsible for providing quality oversight to the revision, review, and approval of controlled documents.
- Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner.
- Responsible for providing input and support as appropriate into the creation of new controlled documents.
- Works with QA Management and other Departments to identify gaps in controlled documents, and recommends solutions.
- Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training.
- Participate in inspection readiness activities and corporate audits, Sponsor audits and/or regulatory inspections, as required.
- Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations.
- Assist QA management with the evaluation of learning management systems and other QA technology, as required.
- Assist in the preparation of quality metrics and reports.
- Assist QA management team with other Clinical QA activities as required.
- Requires computer work for up to 85% of the work day
- May require lifting, moving, turning, and packing of items greater than 25 lbs.
- Bachelor’ s degree in scientific or related discipline, or equivalent work experience.
- Minimum 3 years pharmaceutical and/or CRO industry experience.
- Strong computer skills (Outlook, Word, Excel, Access, PowerPoint).
- Good working knowledge of FDA, GCP and ICH regulations, guidelines, and standards governing regulated clinical research and good documentation practices is required.
- Experience working in a GCP environment.
- High level of computer/software proficiency and adaptability.
- Exceptional attention to detail.
- Ability to prioritize multiple daily tasks to meet timelines.
- Strong understanding of Quality Assurance practices and systems.
- Strong independent judgement and decision making abilities.
- Outstanding interpersonal, oral, written communication skills and attention to detail.
- Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Available to travel up to approximately 25% of the time.