Quality Operations Specialist - Pharma/Biotech

Role Overview

The Quality Operations Specialist will partner with site management to supervise the implementation and maintenance of the quality system within manufacturing and production environments continuously. This role is pivotal in monitoring, recording, analyzing, and communicating adverse quality events tied to the manufacturing process, while ensuring the compliance and quality standards of all released batches are upheld firmly.

Key Responsibilities

• Confirm that manufactured products adhere strictly to established company policies, operational processes, and procedures.
• Oversee quality aspects of GMP-compliant manufacturing and allied support functions such as technical operations, engineering, QC laboratories, and supply chain.
• Examine completed incoming material inspection documents, batch records, manufacturing logs, and supervise product changeover and line-clearance tasks along with managing Quality Logs including QA Holds and tags.
• Authorize release of incoming materials, processing phases, and final product batches.
• Engage in thorough investigations addressing non-conformances across incoming materials, QC testing, manufacturing workflows, storage, and finished products.
• Take part in change management activities by acting as change coordinator and providing QA oversight to ensure compliance with company policies.
• Conduct routine walkthroughs of manufacturing, engineering, warehouse, and QC departments to confirm ongoing compliance.
• Support initiatives such as new product introduction, operational excellence projects, and other assignments from leadership.

Candidate Profile

• Possesses a Bachelor’s degree in Natural Sciences (Biology, Chemistry), Engineering, Pharmacy, or related fields.
• Has foundational understanding of quality and compliance management, including regulations pertaining to APIs and biologics.
• Brings a minimum of three years’ experience in pharmaceutical or biopharmaceutical Quality or Compliance (GxP) environments.
• Familiarity with SAP and Trackwise systems is an advantage.
• Capable of rapidly learning products and process flows to assess and resolve quality issues effectively.
• Dedicated to maintaining high quality standards and exemplary work ethics.
• Exhibits strong integrity and reliability in professional conduct.
• Well-versed with GxP regulatory requirements and standard practices.
• Demonstrates effective planning, scheduling, communication, and interpersonal skills, both written and oral.

Additional Information

This is a 6-month contract position requiring a committed individual to uphold quality operational excellence in a regulated environment.