CSO Label And Systems Specialist

Pfizer Groton , MA

Posted 2 months ago

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

Global Clinical Supply (GCS) manages the execution of supply chain strategies to deliver Investigational Medicinal Product to patients involved in Pfizer's clinical research trials across the globe.

Clinical Supply Operations (CSO) is part of the Medicinal Sciences Global Clinical Supply (GCS) Group. Our purpose is to provide packaging, labeling, and logistics solutions to deliver quality patient-focused clinical supplies to the patient. We provide quality clinical supplies in a compliant, timely, innovative and cost-effective manner. We continuously strive to improve our systems, processes and capabilities in collaboration with our Pfizer and external partners in support of developing breakthroughs to change patients' lives.

The Label and Systems Specialist is a member of the Clinical Supply Operations (CSO) team within Global Clinical Supply (GCS), this role will start in the area responsible for stock management, design, initiation, approval and production of labels intended for clinical trial supplies in accordance with Good Manufacturing Practices (GMP). Role may lead to other opportunities in the GCS area based on development planning and business needs.

How You Will Achieve

  • Engage with other in Global Clinical Supply (GCS) or vendors to understand the label design requirements for a clinical study.

  • Be competent in the use of the PRISYM360/other labelling system(s) in order to add new label stock types and manage the timely oversight of the label design/approval/printing process.

  • Using Global procedures, design labels for clinical trial supplies; create the labels in the requested languages and ensure they meet the requirements as defined in the Label Request documents and the country specific Regulatory Templates.

  • Liaise with GCS colleagues and suppliers as needed to request the translation for any phrase that is not currently available in the Phrase Library to enable the design of labels.

  • Liaise with label approvers to ensure the timely approval of labels. Action any changes requested to ensure the final approved label artwork meets study/regulatory requirements.

  • Create documents that contain approved label designs for export to external label vendors.

  • Generate label approval reports to support documentation required for the Trial Master File.

  • Generate/approve Print Requests in PRISYM360 for approved label designs to enable internal label production.

  • Print, re-print and inspect printed labels/blinding disclosures

  • Monitor usage of label media used for label production and liaise with Inventory Management to order label media.

  • Support the Phrase Library Administrator with the routing of phrase translation requests and management of the bi-annual review of Regulatory label templates.

  • Support the collection and reporting of labeling operations metrics to enable better decision making

  • Build collaborative partnership and maintain strong relationships with internal and external partner lines (CSSM, PSQA, Vendors, etc.) by continually evaluating opportunities for process improvement

  • Perform various tasks and support initiatives and projects as assigned by Sr. Director of Labels and Systems

  • Deliver excellent customer service and consistently strive to meet commitments to customers and optimize operational effectiveness.

  • Demonstrate a 'patient focused' and 'quality culture' approach to label operations and subsequent Clinical supply packaging operations.

  • Contribute to continuous improvement initiatives and support internal GMP audits and GMP facility/process inspections, where applicable.

  • Support the creation/revision of label related Standard Operating Procedures (SOPs) / label guidance documents.

  • Act as Responsible Person for Quality investigations, where applicable.

Qualifications

Must-Have

  • Bachelor's degree with 2-3 years of relevant clinical supply chain experience.

  • Must be proficient in Microsoft Office programs.

  • Knowledgeable about project management and prioritization within Clinical Supply Packaging and/or labelling and/or Distribution along with external vendors and uses these to support project progression (e.g. technical, process, plan or system).

  • Demonstrates general understanding of clinical study designs and GMP documentation.

  • Articulate in both verbal and written communication. A strong presenter that can deliver messages within the internal organization and externally with our partners.

  • Excellent customer focused communication and listening skills.

  • Proven interpersonal, facilitation, customer relations and negotiation skills.

  • Demonstrated ability to learn fast and foster a CSO culture of innovation.

Nice-to-Have

  • Continuous Improvement mindset; Lean or Sigma training.

  • Prior experience with supply chain enterprise supply chain systems

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Occasional travel to vendor sites may be required

  • Role requires Pfizer Site presence

Other Job Details:

  • Last Date to Apply for Job: December 3rd, 2021

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Logistics & Supply Chain Mgmt

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Packaging Technician

Pfizer

Posted 9 months ago

VIEW JOBS 5/8/2021 12:00:00 AM 2021-08-06T00:00 ROLE SUMMARY Clinical Supply Packaging (CSP) is part of Clinical Supply Operations (CSO) in the Medicinal Sciences Global Clinical Supply (GCS) organization. Our purpose is to provide packaging solutions based upon a commitment to reliability, trust, confidence and ease of customer interaction to deliver quality packaged clinical supplies to the patient. The Packaging and Labeling Technician must maintain daily compliance to Standard Operating Procedures (SOPs), in accordance to current Good Manufacturing Practice (cGMP) guidelines and is responsible for performing operations to support the packaging and labeling of clinical trial supplies. ROLE RESPONSIBILITIES The Technician will be responsible for Primary Packaging of solid dose drug product by way of manual hand count filling into bottles or by use of minor equipment for automated filling. The technician will also perform Secondary Packaging, inclusive of labeling finished dosage forms, e.g. labeling of filled bottles, ointments, pre-filled vials and labeling of other pre-packaged finished material. The role includes inspection of labels for application to clinical trial supplies, generation and/or utilization of supporting documentation such as packaging batch records and diagrams to facilitate packaging operations. This position is also responsible to maintain the packaging equipment for daily use, including cleaning and general equipment troubleshooting. Responsible for performing primary and secondary operations in a GMP environment, executing operations following instructions on the approved packaging batch records in accordance with cGMPs and safety regulations. * Responsible for completing required GMP documentation to ensure records of equipment used and packaging activities performed are maintained contemporaneously in applicable documentation * Responsible for adhering to SOPs, cGMPs, and all safety requirements involving handling and movement of clinical trial materials * Responsible for using complex software in the current approved inventory system to scan material and perform tasks required for packaging operations * Responsible for managing routine daily, weekly, monthly, and quarterly maintenance and cleaning of the rooms and equipment in the GMP packaging areas * Maintain continuous workflow in order to follow and adhere to production schedules and timelines * Responsible for identifying common equipment/process failures and troubleshoot solutions for operational challenges * Responsible for participating in required meetings as necessary for business updates BASIC QUALIFICATIONS * High School Diploma or equivalent * Understanding of Good Manufacturing Processes (cGMP), experience * 2 years of relevant experience * Excellent documentation skills and attention to detail * Computer literacy in Microsoft Word * Strong computer, scientific, and organizational skills * Application of computer software to procure packaging documentation and facilitate packaging operations * Excellent communication (oral and written) and attention to detail * Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies * Authorization to work in the United States indefinitely without restriction or sponsorship PHYSICAL/MENTAL REQUIREMENTS * Adherence to regulations and rules such as necessary gowning requirements to gain entry and perform daily operations in the packaging areas are required. Regular gowning requirements include: bouffant head covering, face mask, gloves, shoe coverings, safety glasses/goggles * No make-up, nail polish, and/or jewelry may be worn in the packaging areas where daily operations are performed * The incumbent is subject to standing for sustained periods of time as well as walking, pushing, pulling and lifting of equipment and/or materials weighing up to a maximum of 45 pounds * Continuous mental and visual attention as well as manual dexterity to perform packaging and labeling functions is required NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Logistics & Supply Chain Mgmt #LI-PFE Pfizer Groton MA

CSO Label And Systems Specialist

Pfizer