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About the Role

The Quality Associate I, Operations is responsible for "on the floor" Quality activities during product manufacturing and/or packaging, including sampling, inspection, area clearance, and non-conforming event support. This role involves communicating process and issue updates to multiple departments and supervision, identifying and escalating issues, and participating in continuous improvement initiatives.

Responsibilities

Performs physical inspection of in-process and finished product samples.
Collects samples from manufacturing and packaging according to Batch Production Record and procedure requirements.
Becomes competent in processes: 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 archive storage.
May execute computer data entries in CME, JDE, LIMS, and department databases.
Collects retain samples and performs sample evaluation for Annual Product Review.
May backup third party product review/release.
Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components or release testing.
Responds to and escalates events identified during production to Quality Management.
Participates in investigations with the Rapid Response Team as needed.
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 BPR requirements.
Actively participates in training events, and maintains currency with assigned training requirements.
Follows all procedures to ensure a safe and compliant work environment.

Requirements

High school diploma or equivalent.
2-4 years relevant industry experience.
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.
Proficiency with basic math skills.
Basic experience with computers and software applications.
Ability to learn new processes and procedures.
Able to communicate effectively with other departments, management and operational personnel.
Customer/Stakeholder focused.
Proof-reading skills; ability to identify errors.
Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).
Ability to work overtime as needed, including occasional weekend shifts.
Lift 15 lbs.
Walk across plant/warehouse.
Wear appropriate gowning as required.
Ability to read for extended periods of time.

Skills

Oral Solid Dose pharmaceutical manufacturing
Quality Assurance
Basic math skills
Computer and software applications
Enterprise Resource Planning (ERP) system
Documentation
Communication
Teamwork
Attention to detail
Reading and interpreting SOPs
Proof-reading

Experience Level

2-4 years relevant industry experience

Education Level

High school diploma or equivalent