Quality Associate II, Operations - 3rd shift

Quality & Compliance Irvine, California


The Quality Associate II, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.  Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities.  Communicates to multiple departments and supervision to provide timely process and issue updates.  Identifies and escalates issues or problems to appropriate supervision.  Participates as a team member on cross-functional teams.  Participates in reviews and structured processes for continuous improvement. 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Supports one component of the Par business


Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time



% of Time



§  Performs sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes

§  Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements

§  Is capable and competent of working in three or more Manufacturing process types: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, and/or

§  Is capable and competent of working in three or more Packaging process types: APR Inspections, Customer Complaints, Finished Product Inventory, and Finished Product Destructions

§  Follows internal processes related to controlled substances

§  Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures

§  Collects and appropriately labels packaging retain samples, and submits to the archive storage

§  May execute computer data entries in CME, JDE, LIMS, and department databases

§  Supports process validation and qualification activities

§  Quarantines water ports as necessary

§  May backup third party product review/release

§  Maintains collection of hold time study samples for QC analysis

§  Collects and retains samples and performs sample evaluation for APR

§  Backs up QA reviewer of environmental monitoring alarms

§  Monitors movement of controlled substance within their designated facility to and from secured location


Non-Conforming Events

§  Responds to and escalates events identified during production to Quality Management

§  Participates in investigations with the Rapid Response Team as needed

§  Provides quality direction to operations to resolve floor issues, implement corrections, and assure deviations are opened


Process Improvement

§  Participates in gap analysis and recommends revisions to SOPs

§  Collaborates with Manufacturing and Quality partners to identify and implement improvements



§  Conducts GMP walkthroughs of facilities

§  Performs in-process audits to identify adherence to SOPs and BPR requirements

§  Actively participates in training events, and maintains currency with assigned training requirements

§  Participates in and initiates investigations

§  Becomes a Qualified Trainer and trains junior/peer Quality Associates



·        Follows all procedures to ensure a safe and compliant work environment.






Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  High school diploma or equivalent with 2+ years’ relevant experience OR

§  AA/AS degree with 1-2 years’ relevant experience

§  Experience with statistical sampling methods a plus

§  Related discipline and certification in assigned area a plus


Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Ability to communicate and work with teams

§  Attention to detail

§  Strong documentation skills

§  Ability to read and interpret SOPs and function within the scope of procedures




Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Strong proficiency with basic math skills and basic experience with computers and software applications required

§  Able to communicate effectively with other departments, management and operational personnel

§  Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)

§  Proof-reading skills; ability to identify errors

§  Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Lift 15 lbs.

§  Walk across plant/warehouse

§  Wear appropriate gowning as required

§  Ability to read for extended periods of time



Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.