We are currently searching for a skilled professional to join a well-known client's team in St. Louis, Missouri as a Quality Investigator. This remote role will facilitate the consistent and disciplined execution of the investigation system ensuring the completeness and comprehension of the investigations while determining the most probable root cause. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Investigate, write, and close out root cause investigations/corrective and preventive actions (CAPAs)
Implement necessary follow-up verification checks on investigations/CAPAs items
Coach company colleagues to facilitate a focused knowledge transfer regarding quality investigations
Interact with necessary departments and people to investigate root cause and/or write and implement CAPAs
Review company SOPs related to the quality investigational system and assist with improvement/revisions
Attend any investigational-related meetings
Provide daily/weekly reports to management
Minimum of 2 years of GMP Pharma experience required
Knowledge of Manufacturing Packaging and Inspection
Experience performing investigations and writing CAPAs in a Pharma environment
Knowledge of aseptic processing
Strong problem-solving skills and ability to demonstrate analytical thinking skills
Experience with Root Cause Analysis performed in an aseptic environment preferred
Biology or microbiology experience preferred
Experience with FDA compliance and GMP
Knowledge in Design History Files and experience with parenteral devices
Experience with Combination Products FDA Design Control Regulations and Guidance for Devices or Combination Products (21 CFR Part 4, 21 CFR Part 820)
Minimum of Bachelor's Degree 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.