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.

Logistics & Supply Chain Mgmt

#LI-PFE