Philadelphia, Pennsylvania, United States · On-site
This role will support GxP processes and assist operations in various capacities, including providing support for the following programs: Inspection Readiness, Self-Inspections, Quality Management System, Real-Time Produ…
Skills: Quality Assurance, GxP, Inspection Readiness, Quality Management System, Batch Record Review
Philadelphia, Pennsylvania, United States · On-site
Performs a variety of general and routine duties involved in the pre- and post-analytic portions of lab test processing. The drawing, collection, and processing of blood and other specimens from positively identified pat…
Skills: Phlebotomy, Specimen Processing, Patient Identification, Data Entry, Lab Test Processing
Philadelphia, Pennsylvania, United States · Hybrid
$30/hr–$38/hr
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Philadelphia, Pennsylvania, United States · On-site
$15/hr–$507/hr
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Philadelphia, Pennsylvania, United States · On-site
Principal Machine Learning Engineer to serve as a hands-on technical leader for machine learning, predictive modeling, scoring, decisioning, and applied AI initiatives. This role will primarily focus on building, validat…
Skills: Machine Learning, Predictive Modeling, Python, SQL, Spark
Philadelphia, Pennsylvania, United States · On-site
$118k–$156k/yr
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Wilmington, Delaware, United States · Hybrid
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Philadelphia, Pennsylvania, United States · Hybrid
$30/hr–$38/hr
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Philadelphia, Pennsylvania, United States · On-site
The Infection Preventionist (IP) is responsible for identifying, investigating and monitoring healthcare associated infections. The IP actively participates in regulatory activities to ensure compliance with CDC, DOH, NH…
Skills: Infection Prevention, Healthcare Associated Infections Monitoring, Regulatory Compliance, Outbreak Investigation, PPE Training
Philadelphia, Pennsylvania, United States · On-site
$44k–$55k/yr
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Philadelphia, Pennsylvania, United States · On-site
The Radiation Therapist administers radiation therapy treatments as prescribed by the Radiation Oncologists. Performs all other duties as required to assure accuracy and quality of treatments delivered. Education Other G…
Skills: Radiation Therapy, Treatment Accuracy, Quality Assurance
Philadelphia, Pennsylvania, United States · On-site
Performs a wide variety of laboratory procedures using both manual and automated methods. Is expected to show a considerable degree of independent judgment regarding the performance and reporting of results. Actively par…
Skills: Molecular Diagnostics, Laboratory Procedures, Quality Control, Quality Assurance, Clinical Validation
Philadelphia, Pennsylvania, United States · On-site
The Scientific Technician II is an advanced technical post that contributes to the scientific research in a laboratory by performing experiments, recording results and analyzing the resultant data. The Technician II may …
Skills: Experimental Research, Data Analysis, Laboratory Coordination, Personnel Training, Reagent Ordering
Philadelphia, Pennsylvania, United States · On-site
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Skills: Medical Technology, Clinical Laboratory Sciences, Immunohematology, Microbiology, Chemistry
Philadelphia, Pennsylvania, United States · On-site
$60k–$90k/yr
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Skills: Experimental Design, Laboratory Studies, Data Analysis, Manuscript Preparation, Scientific Presentation
Philadelphia, Pennsylvania, United States · On-site
Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of innovative and fascin…
Skills: Analytical Solutions, Business Decisions, Data Science, Predictive Modeling, Machine Learning
Philadelphia, Pennsylvania, United States · On-site
$76k–$97k/yr
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Skills: Pediatric Nursing, Rheumatology Care, Patient Assessment, Patient Education, Injection Administration
Philadelphia, Pennsylvania, United States · On-site
$15/hr–$507/hr
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Skills: Pediatric Nursing, Patient Assessment, Care Planning, Patient Education, Healthcare Informatics
Philadelphia, Pennsylvania, United States · On-site
$48k–$60k/yr
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Skills: Lab Procedures, Scientific Analysis, Critical Thinking, Problem-solving, Analytical Skills
Philadelphia, Pennsylvania, United States · On-site
$44k–$55k/yr
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Skills: Lab Procedures, Scientific Analysis, Verbal Communication, Written Communication, Organizational Skills
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Support GxP processes including inspection readiness, self-inspections, and real-time production oversight for aseptic filling and pack operations. Responsible for batch record approval, validation review, and collaborating cross-functionally on CAPA and risk management.
Requires a Bachelor's degree in a science or technical field and 3 years of experience in pharmaceutical manufacturing and quality. Candidates should be proficient in Lean principles and possess strong communication skills for a 2nd shift position.
This role will support GxP processes and assist operations in various capacities, including providing support for the following programs: Inspection Readiness, Self-Inspections, Quality Management System, Real-Time Production support, Line Clearance and Oversight, and Validation/Qualification activities.
This is a 2nd Shift position, requiring a long-term dedication to the shift. Hours are 2:30pm-10:00pm Monday thru Friday.
Typical Accountabilities
Support specific Quality Operations processes within assigned area:
External Audit Readiness - support the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits, inspections, and response process as applicable.
Self Inspection Program – Assist in developing and performing the site’s annual self inspection plan to ensure Quality standards are upheld in advance of external regulatory audits.
Batch Record Review/Approval – act as the final signatory on production records ensuring data integrity and right first time execution of the production records. Partner with operations teams to remediate errors and improve execution of production standards.
Line Clearance and Oversight – conduct daily walk through inspections (GENBA) of the Aseptic Filling, Pack Operations, and supporting areas throughout the facility to confirm GMP processes and standards are being followed.
Validation Review/Approval – support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design
Work cross functionally with other Quality teams to support:
Acceptable Quality Limit (AQL) Inspections
Deviation Investigations and CAPA Planning
Quality Risk Management
Product Complaint Investigations
Change Control Planning and Execution
GDP Data Review and Trending
Partner and support operations functions related to Quality standards and regulatory expectations.
Provide guidance and support to cross-functional teams, in risk management, compliance and sharing valuable observations and takeaways.
Lead and implement simplification and improvement initiatives in collaboration with other quality assurance colleagues.
Help update training content and support training sessions passionate about quality standards, compliance, and inspection preparation for staff at various levels.
Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.
Essential:
Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, or Chemistry
3 years’ experience within pharmaceutical manufacturing and quality
Strong orientation for continuous improvement and process streamlining and optimization.
Experience applying Lean principles and delivering change initiatives within a structured framework.
Self-motivated individual that works independently.
Effective communication and interpersonal skills are required.
Desirable:
Project management experience
Lean manufacturing experience
Some experience in business process/ quality system management.
Knowledge of/ experience with newer digital tools and technologies related to quality systems management.
Regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
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