QA Associate II

PCI Pharma Services•San Diego, CA

2d•Onsite

About The Position

The QA Associate II is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate II leads projects, trains junior staff, coordinates daily activities, independently provides quality oversight and support on the floor during manufacturing operations, ensures documents are reviewed for completeness and accuracy. Promotes cGMP environment and follows SOP.

Requirements

Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
Minimum of two to four (2-4) years of experience in documentation, QA, or equivalent.
Knowledge of cGMP regulations and good documentation practices preferred.
Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade.
Demonstrated ability to follow detailed directions in a laboratory environment.
20/20 vision (natural or corrected)
Ability to see and differentiate among colors.

Responsibilities

Manages the review of records and associated data in support of GMP operations activities (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records)
Assists in the review and approval of internal production batch records and associated data for product disposition.
Performs the review and data entry for calibration, preventative maintenance and validation activities.
Supports the Red Tag and Asset Management Process.
Executes QARM responsibilities.
Designated subject matter expert during AQL inspection Processes
Technical Quality documentation initiation, revisions, and deletions.
Assists in the review and approval of executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product batches
Performs real time, on -the-floor documentation review during commercial packaging and labeling activities.
Sterile gown qualified to support cGMP activities in sterile suites.
Oversees scheduled facility walk-throughs and material destruction.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
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.
Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture.