SDO_Quality Assurance Specialist

PCI Pharma Services•San Diego, CA

6d•Onsite

About The Position

The Quality Assurance Specialist will support investigation for clinical trial and packaging/labeling and distribution operations. This full-time position will report to the Quality Operations Director, focusing on supporting the Quality department with inspection, product or material release, document control, production monitoring, tracking quality metrics, and assisting with validations, preventative actions, audits, and continuous improvement. This position will report to the Quality Assurance Manager.

Requirements

High School Diploma and/or 3-5 years related experience and/or training.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Nice To Haves

3+ years of experience in Quality Assurance within a cGMP-regulated environment.
Knowledge of Six Sigma / A3 problem-solving methodologies.

Responsibilities

Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.
Perform document change control activities as needed.
Perform and lead in investigations, NCMRs and Complaints.
Track and monitor CAPAs.
Perform training as needed.
Support Distribution activities.
Collect quality metrics.
Support the Quality Operations Director with internal, supplier, regulatory and customer audits.
Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor.
Perform QC inspection or release of incoming GMP materials according to appropriate material specifications.
Ensure department and company goals are met.
May perform other department tasks.