Quality Control Contractor

Piscataway, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Quality Control Contractor in Chicago, Illinois. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Oversees the development and implementation of quality assurance procedures governing the facility quality systems and ensures compliance with cGMP regulations, customer expectations and company policies
  • Oversees the Supplier quality function and ensures procedures and systems are in place to evaluate, control and monitor incoming product quality. Ensures suppliers are thoroughly evaluated, scrutinized and approved per procedures to ensure incoming material meet client standards and cGMP
  • Oversees the External Audit program and leads supplier audits globally as well as within the US
  • Maintains strong supplier relations and interfaces with suppliers to resolve any quality findings, supplier complaints, etc.
  • Performs quality assurance walk-through audits and/or internal audits of manufacturing, laboratory and warehouse areas to ensure compliance with cGMPs and company procedures
  • Prepares audit agenda, audit checklists, audit reports and approves audit responses
  • Monitors supplier change notifications and supplier complaints
  • Collaborates with functional leads to assess quality impact on product and necessary corrective actions
  • Leads internal investigations, performs root cause analysis using appropriate tools and implements necessary CAPAs
  • Performs gap assessments, quality risk assessments and leads quality improvement efforts
  • Monitors effectiveness of Quality systems, generates quality system event metrics and trend analysis for management review, escalates issues and drives resolution
  • Assists with quality improvement efforts in the QC lab, which may include but not limited to revising QC procedures, improving processes to drive efficiency, assisting with lab investigations, enhancing the stability program, training lab personnel
  • Stays current on Compliance matters, recent 483’s / warning letters, regulations and industry trends
  • Has familiarity with 21 CFR PART 210, 211, 11 and 820, USP requirements, FDA and ICH guidance

EXPERIENCE

  • At least 5 years’ relevant industry (Biotech/Pharma) experience
  • Knowledge of GMPs and their application in the commercial environment is required
  • ASQ certified quality auditor (CQA) preferred 

EDUCATION

  • BS degree in life sciences (Biology, Chemistry, etc.) with 7-10 years’ relevant industry (Biotech/Pharma) experience
  • MS degree in life sciences preferred

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.

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