QA Manager

Posted: 9/16/2019 10:11:36 PM

Job Snapshot

Location: Miramar, FL, US
Posting ID: 6934680

Job Summary



Responsibilities
  • Perform internal audits of all areas identified in the internal audit schedule, and ad-hoc/for-cause audits as required, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
  • Ensure that internal audit observations are being addressed and that the agreed corrective and preventative actions are completed on time.
  • Oversee DEA compliance and reporting activities including maintaining registrations, security of controlled drug storage areas, inventory reporting, permits and quotas.
  • Oversee compliance with Florida Department of Business and Professional regulations including pedigree requirements, registration and licensing.
  • Develop and implement appropriate business processes and controls including SOP, in order to maintain effective quality standards
  • Develop metrics and manage communication and tracking system to assure CAPA closure
  • Manage the Supplier Qualification Program to ensure raw materials, intermediates, and products supplied are of suitable quality for manufacturing processing and/or commercial distribution
  • Develop and maintain effective relationships with Clients, Affiliates as well as Operation Directors, and Supply Chain Group in order to ensure timely audits, communication, and resolutions to discovered GMP deficiencies and/or concerns
  • Responsible for the operation of GMP Auditing including project planning and resource management
  • Evaluation of SME audit responses to ensure each observation has been adequately approved


Requirments
  • Prior cGMP experience in Pharmaceuticals
  • Prior management experience
  • Experience with CAPAs


Envrionment
  • cGMP/GLP envrionments
  • Monday-Friday 8:30-5:00










About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Skills

auditing
information security
internal auditing
metrics
pharmaceuticals
project planning
resource management
scheduling
management
business process
distribution (business)
storage (warehousing)
manufacturing
certified global meeting planner
good manufacturing practices
corrective and preventive action (capa)
drug enforcement agency

About CareerCircle

The statistic has gone viral that there will be a talent shortage of 85.2M people by 2030. CareerCircle was founded in the spirit of finding solutions to address the pending skills gap versus falling victim to it. With so many capable people wanting to find employment and employers needing partners to achieve their goals, CareerCircle is here to provide a bridge.

At CareerCircle, we recognize that CareerskillingTM is the fastest path to improved performance and securing your ideal role. To advance your skills, you need access to the highest caliber of online education technology that is delivered in a meaningful way. Here is where we come in. We partner with experts in education technology to deliver unique learning experiences that can be instructor-led or self- paced, supplemented with the necessary support for optimal results. By completing the coursework provided by these groups, candidates gain the ability to be marketed to recruiters and potential employers with an emphasis on acquired skills and performance, versus limited work history or listed resume experience. In the end, your journey of advanced education leads to higher pay, flexibility, and a better life.

Contact Information

Name: Nicolas Pardo
Phone: (954) 717-3547