2nd Shift Pharmaceutical Manufacturing Tech
The objective of this position is to perform operations within the Finishing Operations Team to support the manufacture of radioactive products in a timely and compliant manner based on business needs. Incumbent ensures that the integrity and quality of the products produced comply with the associated operating procedures to meet all cGMP, regulatory, and safety requirements. This position may require mandatory overtime, as needed, supporting finishing operations on holidays, weekends, and/or late and early production shifts.
Demonstrates the competency of all major duties and responsibilities of a Finishing Operations Tech I.
Plans and adjusts own schedule to meet changing priorities on a daily basis. Coordinates multiple tasks daily and weekly.
Checks and reviews data for accuracy and completeness independently.
Interacts with group members to coordinate functions and maximize efficiency.
Resolves routine manufacturing problems independently or by utilizing the appropriate technical group resource and problem solving techniques.
Utilizes knowledge, experience, and group resources to make decisions regarding routine issues.
Communicates effectively with vendors.
Reads operation manuals and contributes to writing of SOP's.
Contributes to preparation and completion of deviation reports.
Communicates effectively in situations involving pressure.
Working hours: 7:00 AM - 3:30 PM
--Demonstrates the ability to apply knowledge of the cGMP Regulations (parts 210 and 211) to routine situations.
--Applies theoretical knowledge from the site handbook of radiation protection to routine workplace situations.
--Demonstrates knowledge and fundamental understanding of operating computer-controlled production equipment.
--Performs numerous tasks ranging from basic to complex functions.
--Demonstrates knowledge of applicable software.
--Performs inventory transactions and troubleshoots discrepancies.
--Recommends process/quality improvements. Offers innovative solutions to manufacturing problems. Takes an active role in implementing approved changes.
--Recognizes and suggests personal objectives which complement and support group and organizational goals. Influences others in meeting their group objectives through support and cooperation.
--Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of personal protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Associates Degree in a science related field and 1-2 years experience in a pharmaceutical/biotech manufacturing environment or a High school diploma with 3 -5 years work experience in a manufacturing and/or quality environment. Prior experience working in a clean-room environment with cGMP s is a plus.
Knowledge of product portfolio and manufacturing processes.
Ability to work according to cGMP guidelines.
Demonstrated working knowledge and approved user of radioactive materials.
Practical working knowledge of computer systems and platforms.
In depth knowledge of manufacturing equipment and new technologies.
Hands-on experience with manufacturing processes and problems, including trouble-shooting, scale-up, and optimization efforts.
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