QA Training and Audit Specialist - Operations
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As aQA Training and Audit Specialist in Gaithersburg, MD. you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
- Providing training and regulatory support to the Development Quality organization.
- Training support responsibilities and experience may include the following: providing support for the GxP training function in a pharmaceutical manufacturing environment, maintenance of training records, assisting with design, development and delivery of training and educational programs.
- Regulatory support responsibilities and experience may include the following: Planning and coordination of Corporate, Customer and Regulatory Agency GMP audits, coordinating the review and responses to audit observations and ensuring timely completion of tasks. Coordinating regulatory surveillance activities and tasks. May travel nationally/internationally and represent company during audits.
- Assist the QA Manager in the design, development and delivery of training and educational programs.
- Assist the QA Manager in developing training and regulatory metrics to present to management on a periodic basis.
- Serves as the primary support person for external/internal users of the LMS, including designing and maintaining documentation such as training materials, customer service templates/emails, work instructions and FAQ's.
- Responsible for all training data entry and ensuring all training data (electronic/paper) is archived accordingly.
- Responsible for identifying, troubleshooting, and resolving problems with LMS course design. Monitors proper functionality and communication with the LMS and multiple related- applications.
- Proactively looks for opportunities to improve level of compliance and efficiency by suggesting LEAN improvements to the training processes and procedures.
- Assist the QA Manager in planning and coordinating Corporate, Customer and Regulatory Agency GMP audits and any associated responses.
- Assist the QA Manager in improving and maintaining a regulatory surveillance program for Development Quality organization in support of Biopharmaceutical Development including reviewing regulatory documentation for compliance and coordinating gap assessments as needed.
- Complete routine archive operations for GLP, GCP and GMP paper records generated at the Gaithersburg site(s) under the supervision of archive personnel in accordance with approved procedures as required.
- BS or BA University degree is required
- Minimum 2 years Quality experience.
- Good listening skills, interpersonal savvy, and peer relations
- Basic understanding and application of GxP principals, concepts, practices and standards
- Excellent computer skills, including a high level of comfort with web-based programs in addition to the standard office applications (MS Office, Internet applications, etc.) and understanding of electronic systems such as controlled document/training/compliance systems
- Ability to transfer knowledge: developing training materials and conveying complex concepts
- Strong analytical and organizational skills and the flexibility to handle multiple tasks and deadlines
- Demonstrated experience with regulatory and/or internal audits and inspections
- Experience developing and running metrics
- Understanding and use of LEAN and/or Operational Excellence (FMEA, DMAIC, root cause analysis etc.) concepts
- Application of risk-based strategy
- Information Technology and web literate with experience in content management systems, LMS maintenance, instructional design and development of online learning materials. Demonstrated proficiency with e-learning concepts, tools, and development platforms (i.e. HTML, HTML5, Articulate, Captivate, Camtasia, Photoshop, Dreamweaver, JAVA, etc.)
Next Steps – Apply today!
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.