We are currently searching for a skilled professional to join a well-known client's team as a Computer Systems Validation Professional in Brisbane, California. This creative and critical thinking role will draft and execute PQ protocols for QC analytical instruments, including HPLCs, cell counters, and spectrophotometers. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Ensure that the company's validation policies and procedures are followed to maintain compliant and on-time delivery
Oversee validation deliverables and drive the project to successful completion by confirming daily tasks and project milestones are met
Coordinate activity, deliverables, and tasks with other company stakeholders
Prepare impact and risk assessments, validation protocols, and summary reports
Minimum of 5 years of experience in related fields required
Strong understanding of cGxP standards and risk-based validation
Knowledge of FDA guidance and industry standards (i.e., Quality Systems, GAMP, 21CFRPart11, and EudraLex Volume 4 Annex 11)
Detailed knowledge of cGMP manufacturing and regulatory requirements for biotechnology, pharmaceuticals, and medical devices
Demonstrated ability to create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations
Experience translating system-requirement specifications into executable validation protocols
Proficient computer skills and fluent with Microsoft office applications
Excellent interpersonal, verbal, and written communication skills required in this collaborative work environment
Strong project management and problem-solving skills
Minimum of Bachelor's Degree in Engineering, Computer Science, or another relevant scientific field required
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.