Compliance Specialist
4 weeks ago
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
Compliance Specialist in Newark,DE ,
Shift:
Days: Monday to Friday schedule (4 days a week, 9 hours a day)
Hours: 1st Shift
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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.
In
Operations
, we have a big ambition – to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
The
AstraZeneca Newark Supply Site in Newark, DE
, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of sophisticated products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.
The core responsibilities of the role are as follows:
Manage all Compliance programs and lead/execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies.
Provide oversight/process ownership for core Quality Systems including but not limited to; Complaints, Quality Events / Deviations, CAPA, Change Control, Product Reviews, Supplier Quality, Internal Audit Program, and other Quality Systems as needed to support the site.
Drive continuous improvements efforts through
monitoring/evaluation
of site systems & processes against current Compliance requirements and influencing key stakeholders on recommended Compliance improvements.
Host/lead/manage inspections of site by External Customers, internal assessors, and Regulatory authorities.
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.
Qualifications:
Education:
Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering
Required:
Minimum of five years experience in the pharmaceutical industry and/or FDA experience and minimum 3 years in Quality
Assurance/Compliance.
Strong knowledge of global regulatory and cGMP requirements, industry best-practices
Strong familiarity with production operations.
Strong leadership, project management, and technical writing.
Desired:
Minimum of seven (7) years in QA/Regulatory Compliance in the pharmaceutical industry.
Prior experience leading/managing regulatory inspections.
Experience managing Quality Systems
ASQ certifications (e.g. CQA, CQE, CQM).
Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
Date Posted
05-Feb-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.
#J-18808-Ljbffr
-
Environmental Compliance Specialist
2 weeks ago
Newark, United States FMC Corporation Full timeInterface with state and federal environmental agencies on permit compliance and renewal, site inspections, regulatory interpretations, and advocacy. Host agencies during site audits/visits. Develop, maintain and administer systems to stay in complia Compliance Specialist, Environmental, Compliance, Specialist, Industry, Manufacturing
-
Trade Specialist
2 weeks ago
Newark, United States Hire Point Recruiting Full timeAbout the job Trade Specialist Trade SpecialistAbout Us: Our client is a prestigious law firm known for providing exceptional legal services in the field of international trade law. We are seeking a highly skilled and motivated Trade Specialist to join our dynamic team of legal professionals. If you have a deep understanding of trade regulations, customs...
-
Marketing Specialist
1 month ago
Newark, United States Diamond State Financial Group Full timeThe Marketing Specialist is responsible for maintaining a cohesive marketing presence for Diamond State Financial Group. Responsibilities include managing the creation of corporate marketing materials and social media campaigns, maintaining our website, and working with the event coordinator and advisors to promote client events. The Marketing Specialist...
-
Client Specialist
1 day ago
Newark, United States Allegiance Trucks Full timeOnsite Release of Information Specialist - Hot Springs, ARSummary of Position:The Release of Information Specialist (ROIS) initiates the medical record release process by inputting data into Verisma software. The ROIS works quickly and carefully to ensure documentation is processed accurately and efficiently. This position will be based at a Verisma client...
-
Procurement Specialist
1 week ago
Newark, United States Munich Airport NJ LLC Full timeThe Procurement Specialist will contribute to sourcing activities, supplier evaluations, and contract management within the procurement process, all while ensuring compliance with corporate governance and ethical standards. This role will assist with the development of a contract quality assurance framework to enhance compliance and overall performance. The...
-
Procurement Specialist
2 weeks ago
Newark, United States Munich Airport NJ LLC Full timeJob DescriptionJob DescriptionThe Procurement Specialist will contribute to sourcing activities, supplier evaluations, and contract management within the procurement process, all while ensuring compliance with corporate governance and ethical standards. This role will assist with the development of a contract quality assurance framework to enhance compliance...
-
Human Resources Specialist
4 weeks ago
Newark, United States Transportation Security Administration Full timeSummary Securing Travel, Protecting People - At the Transportation Security Administration, you will serve in a high-stakes environment to safeguard the American way of life. In cities across the country, you would secure airports, seaports, railroads, highways, and/or public transit systems, thus protecting America's transportation infrastructure...
-
Procurement Specialist
1 week ago
Newark, United States Munich Airport US Holding LLC Full timeThe Procurement Specialist will contribute to sourcing activities, supplier evaluations, and contract management within the procurement process, all while ensuring compliance with corporate governance and ethical standards. This role will assist with the development of a contract quality assurance framework to enhance compliance and overall performance.The...
-
Transportation Specialist
1 week ago
Newark, United States Catholic Charities Family Community Services Full time**Transportation Specialist** **Job Details** **Level** Entry **Job Location** Hannick Hall Residence - Newark, NY **Position Type** Full Time **Education Level** High School Diploma or GED **Salary Range** $16.00 - $16.50 Hourly **Travel Percentage** Over 50% **Job Shift** Days w/occasional evenings **Job Category** Behavioral Health **Description** Under...
-
Pharmacy specialist
4 weeks ago
Newark, United States Collabera Full timeJob DescriptionJob Description100% Remote for NJ candidate with NJ Active licenseResponsibilities:Process prior authorizations received via helpline, evaluating medical necessity for specific drugs based on medical criteria.Interact with members, physician office staff, pharmacies, and internal stakeholders for eligibility, coverage determination, and claims...
-
Support Specialist
4 weeks ago
Newark, United States Michaels Stores Full timeSupport Specialist page is loaded **Support Specialist** **Support Specialist** locationsSecaucus-400 Mill Creek Dr time typePart time posted onPosted Yesterday job requisition idR00131336 Store - NWK-SECAUCUS, NJ**We're here for the Makers! Come be a part of the team where innovation and teamwork come together to support the most exciting missions in the...
-
GxP/SOX Validation Specialist
16 hours ago
Newark, United States Advanced Software Talent Full timeOur direct client is seeking a GxP/SOX validation specialist for the following opening: You will handle, IT GxP Systems will work to maintain a stable GxP systems environment to enhance performance, uptime, and compliance. This person will implement IT GxP policies, procedures, and best practices and serve as the organization s IT GxP Systems.This is an...
-
Procurement Specialist
2 weeks ago
Newark, United States Munich Airport US Holding LLC Full timeThe Procurement Specialist will contribute to sourcing activities, supplier evaluations, and contract management within the procurement process, all while ensuring compliance with corporate governance and ethical standards. This role will assist with the development of a contract quality assurance framework to enhance compliance and overall performance. The...
-
Document Imaging Specialist
4 days ago
Newark, United States University HealthCare Alliance Full timeIf you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of America) This is a Stanford Health Care - University Healthcare Alliance job. A Brief Overview Health Information Management Services (HIMS)...
-
Clinical Nurse Specialist
2 weeks ago
Newark, United States ChristianaCare Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...
-
Clinical Nurse Specialist
7 days ago
Newark, United States ChristianaCare Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...
-
Clinical Nurse Specialist
1 week ago
Newark, United States ChristianaCare Careers Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...
-
Clinical Nurse Specialist
2 weeks ago
Newark, United States ChristianaCare Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...
-
Clinical Nurse Specialist
2 weeks ago
Newark, United States ChristianaCare Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...
-
Clinical Nurse Specialist
1 month ago
Newark, United States ChristianaCare Full timeAre you seeking an amazing nurse leadership role as a Clinical Nurse Specialist with our Perioperative Services team? Christiana Hospital & Wilmington Hospital is the only Level I trauma service on the East Coast corridor between Philadelphia & Baltimore and has been honored repeatedly as "One of America’s Best Hospitals" by U.S. News & World Report and...