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GMP Cleaning Lead Site Operations

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Frederick, MD

Employer:  AstraZeneca
Job Type:  Full Time

Description

Introduction to role

Are you ready to lead a high-performing team in a dynamic and evolving environment? As the GMP Cleaning Lead Site Operations, you will ensure that our operating shift teams are fully trained and compliant to support FMC's GMP cleaning needs around the clock. You will be responsible for ensuring that your team meets all deliverables for required GMP cleanings, handles ad hoc cleaning requests, and advances issues to manufacturing when vital. Additionally, you will maintain deviation resolution and track GMP Cleaning training for your designated shift team. Join us in making a difference every day!

Accountabilities

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities, and tasks associated with this job title:

- Ensure Compliance with FMC's GMP cleaning program

- Attend Manufacturing Tier meetings to align with production requirements

- Call out issues with implementing GMP cleaning SOPs, such as the need for alternative equipment

- Liaise with service providers to ensure the GMP cleaning team meets deliverables and call out issues related to shift availability or absenteeism

- Verify that cleaning log books at the end of the shift meet standards

- Properly turn over unresolved items to the oncoming shift as appropriate (e.g., gowning supplies) that may require resolution or partner concern

- Support on-floor Genba activities up to 80% of the time

- Perform other duties as assigned to support Site OPS and the broader F&E Community

- Conduct activities and interactions consistent with What we value 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.

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

Essential Skills/Experience

- High school diploma or equivalent

- Bachelor's degree or 4 additional years of work experience in lieu of degree

- AA or 2 additional years of work experience in lieu of a degree

Desirable Skills/Experience

- Bachelor's degree

- Spanish language fluency

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

At AstraZeneca, we foster an environment of trust in our complex and ever-changing manufacturing sites. Our sites are more than just places to work; they are homes where you feel supported while tackling interesting challenges. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean attitude and sustainable practices. Every change we make is aimed at delivering better outcomes for our patients.

Flexibility in work hours and schedule required.

Ready to make a difference? Apply now!

The hourly rate of compensation for this position ranges from $19.49 per hour to $29.12 per hour. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.
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