Quality Assurance Lead
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization for the position of Quality Assurance Lead. This role is located in Canton, Massachusetts and will be responsible for investigating events and non-conformances encountered during GMP operations, such as manufacturing, testing or holding of drug products. We are looking for an experienced investigator able to effectively investigate medium and high risk events.
- Partner with operation; work on the shop floor and in a team environment to provide on the spot input and guidance in responding to deviations
- Lead investigation teams
- Make recommendations to department management regarding results of investigation and process improvements
- Work with impacted department management to identify appropriate corrective and preventive actions
- Assist in tracking of CAPAs through completion
- Ensure a constant state of inspection readiness ensuring that deviation and CAPA documents remain current
- Provide support during internal and external audits and ensure that assigned audit observations are addressed quickly and completely to maintain readiness levels
- Perform CGMP audits
- Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with CGMP, regulatory and internal requirements such as company guidelines and approved procedures
- 5 – 7 years, depending on education or a minimum of 12 years of relevant industry experience
- Master’s Degree of Science in Engineering or Life Sciences and 5 years of industry experience
- Bachelor’s Degree of Science in Engineering or Life Sciences and 7 years industry experience
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.