Quality Associate l - 2nd Shift
Job Summary - a concise overview of the job
The Quality Associate I, 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, and non-conforming event support to resolve in-process issues. 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 physical inspection of in-process and finished product samples as assigned and according to the production schedule
§ Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
§ Becomes competent in at least one process: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging
§ Follows internal processes related to controlled substances
§ Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials
§ Collects and appropriately labels packaging retain samples, and submits to the archive storage
§ May execute computer data entries in CME, JDE, LIMS, and/or department databases
§ Maintains collection of hold time study samples for QC analysis
§ Collects and retains samples and performs sample evaluation for APR
§ May backup third party product review/release
§ Responds to and escalates events identified during production to Quality Management
§ Participates in investigations with the Rapid Response Team as needed
§ Performs manufacturing and packaging room inspections and release
§ Provide quality direction to operations to resolve floor issues, implement corrections, and assure deviations are opened
§ Collaborates with Manufacturing and Quality partners to identify and implement improvements
§ Conducts GMP walkthroughs of facilities
§ Learns how to perform in-process audits to identify adherence to SOPs and BR requirements
§ Actively participates in training events, and maintains currency with assigned training requirements
§ 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 0-1 year of relevant experience
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.
§ Proficiency with basic math skills and basic experience with computers and software applications required
§ Ability to learn new processes and procedures
§ 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 & 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.