Drug Product Manufacturing Associate I - Formulations - 2nd Shift

PCI Pharma Services•San Diego, CA

7d•Onsite

About The Position

The Drug Product Formulations Manufacturing Associate I is responsible for the execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. This role works with the Drug Product Manufacturing team to ensure the successful completion of various cGMP activities. The Manufacturing Associate I will learn and demonstrate proficiency in both the technical aspects and the quality systems that govern cGMP manufacturing. This position is for the 2nd Shift, with hours from 2 PM to 10:30 PM, and is eligible for a 10% pay differential.

Requirements

Bachelor’s degree in a Life Sciences discipline or equivalent preferred.
Zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions, preferably in a scientific or manufacturing environment.
Familiarity with cGMP, manufacturing, machine operations, and data entry is preferred.
Must be familiar with Microsoft Office applications.

Responsibilities

Under the guidance of senior manufacturing operators, performs various routine manufacturing tasks while adhering to the guidelines of established Standard Operating Procedures (SOP’s) and cGMP regulations.
Supports the implementation of production and manufacturing procedures.
Performs visual inspection of tanks and bulk drug substances.
Prepares components, media, buffers, and other solutions as needed.
Accurately documents data and completes batch records as needed.
May cross train and/or focus in various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components.
Expected to perform manufacturing operations in a sterile suite.
Preparation of material and components for sterilization in autoclave or dehydrogenation oven.
Reliably executes well-defined SOP’s.
Assists other technical personnel with troubleshooting and engineering activities.
Collects and disposes of lab wastes according to established Environmental Health & Safety (EHS) procedures.
Responsible for routine maintenance of production equipment.
Maintains cGMP environment according to the production needs of the Drug Product group.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI's cultural values and aligns daily actions with department goals and company culture.