Clinical Supply Operations Packaging Technician
Job Description
Job Description
The Packaging and Labelling Technician must maintain daily compliance to Standard Operating Procedures (SOPs), in accordance with current Good Manufacturing Practice (cGMP) guidelines and is responsible for performing operations to support the packaging and labelling of clinical trial supplies.
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 labelling finished dosage forms, e.g. labelling of filled bottles, ointments, pre-filled vials and labelling 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 T4 position is also responsible to lead execution of designated packaging operations with designated packaging technician support, and maintain packaging equipment for daily use, including cleaning and general equipment troubleshooting.
Responsibilities include, but are not limited to:
Responsible for performing primary and secondary operations in a GMP environment, leading execution of designated packaging operations with designated packaging technician support, performing packaging 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 identifying required delivery and process improvements that drive increased efficiency, throughput and quality
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
Qualifications
Must Have
High School Diploma or equivalent
6+ years of relevant experience
Understanding of Good Manufacturing Processes (GMP)
Excellent documentation skills and attention to detail
Computer literacy in Microsoft Word
Excellent communication (oral and written) skills and ability to effectively communicate packaging operations and requirements
Ability to work independently and as lead of a designated packaging operation, self-motivated, adaptability, and a positive attitude
Ability to work in fast paced environment with flexibility to changing priorities
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Nice to Have
Application of computer software to procure packaging documentation, perform inventory adjustments and reconciliations, and facilitate packaging operations
Strong computer, scientific, and organizational skills
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 labelling functions are required
Other Job Details
Work Location Assignment:On Premise/Onsite
The salary for this position ranges from $31.82 to $53.04 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Connecticut - Groton location.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
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