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
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 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.
How You Will Achieve
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.
High School Diploma or equivalent
Excellent documentation, communication ( oral and written) skills and attention to detail.
Strong computer, scientific, and organizational skills
Application of computer software to procure packaging documentation and facilitate packaging operations.
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.
Understanding of Good Manufacturing Processes (cGMP), experience.
2 years of relevant experience working in a regulated environment.
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.
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
No make-up, nail polish, and/or jewelry may be worn in the packaging areas where daily operations are performed.
Other Job Details:
Last Date to Apply for Job: October 20th, 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 ActPfizer 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 EligibilityPfizer 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