QA Associate I

PCI Pharma Services•San Diego, CA

1d•$22 - $24•Onsite

About The Position

The QA Associate I 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 I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Understanding and execution of basic cGMP and GDP principles is required.

Requirements

High School Diploma or equivalent required.
Zero to two (0-2) years of relevant experience in documentation, QA, or equivalent.
Ability to work independently, within prescribed guidelines, and as a team member.

Nice To Haves

Bachelor’s degree in a Life Sciences discipline preferred
Knowledge of cGMP regulations and good documentation practices preferred.
Experience with Computerized Maintenance Management Software (CMMS) preferred.
Demonstrated ability to follow detailed directions in a laboratory environment preferred.

Responsibilities

Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records).
QMS process support for change controls and quality investigations.
Performs AQL inspection of final filled product.
Performs area line clearance operations in support of manufacturing operations.
Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
Generate labels for cGMP use.
Reviews, approves, and reconciles labels for cGMP use.
Sterile gown qualified to support cGMP activities in sterile suites.
Assists in the review and data entry of Calibration and Preventative Maintenance records.
Assists in the review of equipment and facility related Change Control documentation.
Maintains equipment files and archives.
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.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.