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Overview

Company

Original Job Post

WhiteCrow Research · 2 days ago

Associate I, Quality Operations

Chestnut Ridge, NY

Full-time

Onsite

Entry Level

2+ years exp

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Responsibilities

The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.

Quality activities including product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.

Communicating to multiple departments and supervision to provide timely process and issue updates.

Identifying and escalating issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.

Participating in reviews and structured processes for continuous improvement.

Performing physical inspection of in-process and finished product samples as assigned and according to the production schedule.

Collecting samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.

Becoming competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.

Following internal processes related to controlled substances.

Performing GMP related verifications such as line clearances, cleaning, room inspection, and materials

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

Executing computer data entries in CME, JDE, LIMS, and/or department databases.

Collecting retain samples and performs sample evaluation for Annual Product Review.

Backing up third party product review/release.

Performing sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.

Responding to and escalates events identified during production to Quality Management.

Participating in investigations with the Rapid Response Team as needed.

Collaborating with Manufacturing and Quality partners to identify and implement improvements.

Conducting GMP walkthroughs of facilities.

Learning how to perform in-process audits to identify adherence to SOPs and BR requirements.

Actively participating in training events, and maintains currency with assigned training requirements.

Following all procedures to ensuring a safe and compliant work environment.

Qualification

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Documentation skillsInterpretation of SOPsCommunicationTeamworkAttention to detail

Required

High school diploma or equivalent with 2-4 years of relevant industry experience (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