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.

Description:

12 Hour Night Shift Role

The Aseptic Control Technician Autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.

Essential Job Functions:

• Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Complete required training.
• Perform visual inspections.
• Use MODA to collect and analyze samples.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Perform routine sampling activities and associated data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Provide 24/7 "on-call" support to others.
• Provide feedback on service and quality issues on a timely basis.

Minimum Requirements:

• High school graduate or GED required
• Minimum 1-2 years experience in a pharmaceutical production environment or regulated manufacturing environment
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language
• Good attention to detail is required. Individual must be capable of keeping accurate

  records and performing mathematical calculations.

 Preferred Background:

• Working knowledge of MODA, Microsoft applications, SAP, KRONOS, and Trackwise
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

Internal/External Contacts & Customers:

• Quality Control staff
• PET staff

Required Competencies:

• Basic knowledge of sterile room techniques, chemical handling and usage
• Mechanical/technical aptitude              
• Ability to work effectively in a team environment
• Candidate should possess the ability to work in a changing/demanding environment

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.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.