QA Specialist/Senior QA Specialist - (Mount Vernon, IN) - Mount Vernon, IN | Biospace
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QA Specialist/Senior QA Specialist - (Mount Vernon, IN)

AstraZeneca Pharmaceuticals LP

Mount Vernon, IN
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Mount Vernon,
United States
Job reference: R-013427

Posted date: Aug. 30, 2017

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 QA Specialist/Senior QA Specialist
in Mt, Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

As a QA Specialist/Senior QA Specialist (level C/D)
, you will be responsible for QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Job Responsibilities:

Major Responsibilities:

  • You will maintain a high level of understanding of relevant production processes and quality systems
  • You will perform the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned:
    • Change Requests
    • Batch Records and associated documentation
    • Product and Component Release transactions in SAP
    • Quality Investigations (Deviations, Product Complaints)
    • Validation Plans, Protocols and Reports
    • Standard Operating Procedures
    • BOS/BOM documents
  • You will collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems
  • You will execute QA processes including batch record review, product disposition, purge audits, line audits, room releases, stability sample management, retain management, and quality issue resolution to maintain the flow of products and documents to meet site objectives
  • You will work with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
  • You will collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices
  • You will stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders
  • You will collaborate in data analysis and report creation on quality metrics and key performance indicators

At this level the incumbent is not necessarily performing all the Major Responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.


Essential Requirements
  • Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor’s degree with 3 years of experience in the pharmaceutical industry in roles covered by GMP oversight.
  • Excellent oral and written communication skills
  • Strong ability and motivation to learn
Desirable Requirements
  • Three years of experience as an operator in a production environment; pharmaceutical experience a plus
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.