Associate I, Quality Operations

Strides Pharma•Chestnut Ridge, NY

9d•Onsite

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, and non-conforming event support to resolve in-process issues. This role communicates to multiple departments and supervision to provide timely process and issue updates, identifies and escalates issues or problems to appropriate supervision, and participates as a team member on cross-functional teams. The Associate I also participates in reviews and structured processes for continuous improvement.

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 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)
Lift 15 lbs.
Walk across plant/warehouse
Wear appropriate gowning as required
Ability to read for extended periods of time

Nice To Haves

Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred
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.