Quality Assurance Specialist II/III - Frederick, MD - Global Operations
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Assurance Specialist II/III in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.
Performs selected quality assurance activities.
This position could be filled as a Quality Assurance Specialist II or III
This is a night shift position
Performs selected quality assurance activities, dependent upon assigned area, including the following:
• Reads, understands, and follows SOP’s and complies with cGMP’s
• Writes new standard operating procedures or revises existing documentation utilizing document management systems
• Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
• Supports the issuance and reconciliation of GMP documentation
• Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP
Performs broad spectrum of routine tasks in their functional area
• Reviews documented information from their functional area, reports abnormalities
• Assists in the implementation of new processes.
• Assists supervisor by assembling metrics as requested for their functional area.
• Provides task-oriented training to Specialists.
• Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
• Represents QA on site committees such as SHE, etc.
• Proposes and implements process and other efficiencies as approved by supervisor.
Identifies process improvements in their functional area
• Coordinates implementation of new processes in their functional area.
• Prioritizes day-to-day support for their functional area and longer term projects or investigations
• Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to their functional area.
• Creates/revises QA documents (SOPs, technical reports, risk assessments) in document management system
• Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS
• Supports internal audits of manufacturing, analytical testing, labeling to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program
• Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.
• Represents QA, as needed, during meetings relevant to their functional area, communicates, tracks all follow-up items through to completion
• Provides guidance to lower-level associates on a daily basis
- Bachelor's degree required; biology, engineering or science-related field preferred
- 3-5 years industry experience
- 3 years of experience in QA preferred
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.