Associate I, Quality Operations
About The Position
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, 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.
Requirements
- High school diploma or equivalent
- 2-4 years’ relevant industry (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)
- 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 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)
Nice To Haves
- Experience with Enterprise Resource Planning (ERP) system is a bonus
Responsibilities
- 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 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 the 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
