Quality Control Associate Scientist

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

Brief Job Description

The following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

• Performs laboratory support.

• Drives the implementation of new technology.

• Provides technical guidance and training for lower level personnel.

• Serves as QC interface with GTO, MS&T, and Development and instrument vendors

• Writes, reviews and approves protocols and reports (e.g. analytical MT, MV and instrument IOQ).

• Coordinates with lab managers to ensure successful execution of technical protocols, leads investigation of exceptional conditions or atypical data.

• Manages on-time delivery of new QC analytical test method and instrument SOPs in support of analytical tech transfer projects

• Approves new QC analytical test method and instrument SOPs

• Represents QC on or owns Quality documents supporting introduction of new analytical technology and new products

• Serves as lead investigator for major deviations and other Quality documents of highly technical nature (e.g. require test method history review and possible revision)

• Assists Sr. Analyst with test method and instrument troubleshooting, review of test methods, SOP review and revision, PQR and regulatory reports etc. as needed

• Conducts or participates in technically demanding projects within QC

• Works under general direction. Follows established procedures to perform job requirements. No instructions needed on a routine basis. General instructions required to perform new activities or special assignments. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

• Contributes to the completion of specific programs and projects. Failure to achieve results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

• Majority of liaison is on internal basis . Liaison normally involves specific phases of a project or operation. External contacts may be frequent and involve routine matters.

• Accomplishes tasks mainly as an individual contributor. May also provide technical guidance to less experienced staff.

• Typical Accountabilities (per AZ framework and regulatory expectations):

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

• In addition, for Managers and Project Team Leaders:

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.

• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Minimum Requirements

• Bachelor's degree: Scientific / Biotech / Pharmaceutical field of study, 4+ years of pharmaceutical or biopharmaceutical industry.

• Master's degree: Scientific / Biotech / Pharmaceutical field of study, 2+ years of pharmaceutical or biopharmaceutical industry.

• PhD: Scientific / Biotech / Pharmaceutical field of study, 1+ years of pharmaceutical or biopharmaceutical industry.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey.

Date Posted

20-Jun-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.