Sr. Operations Specialist, QA at Goodwin Biotechnology Inc

Plantation, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Aug, 26

Salary

0.0

Posted On

20 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Aseptic Manufacturing, Quality Assurance, Deviation Investigations, CAPA, Batch Record Review, SOP Authoring, Audit Support, Data Integrity, Line Clearance, Environmental Monitoring, NetSuite

Industry

Biotechnology Research

Description

Description Scope of Function: The Sr. Operations Specialist, QA is a hands-on, on-the-floor Quality Assurance professional responsible for ensuring GMP compliance during manufacturing operations while exercising independent quality judgment. The role provides real-time QA oversight and acts as an independent QA authority on the manufacturing floor, with responsibility for complex investigations, decision-making, and escalation of quality risks. Specific Duties: · Provide real-time QA presence and oversight for manufacturing operations in classified areas. · Perform routine and ad hoc GMP walkthroughs to assess compliance and aseptic practices. · Act as the primary QA point-of-contact during manufacturing activities. · Exercise independent GMP decision-making, including escalation and stopping operations when required. · Lead and support deviation investigations and CAPAs. · Real-time review and approval of executed batch records, logbooks, and cleaning documentation. · Support media fills, line clearances, and room/equipment release. · Review, author, and revise SOPs, batch records, and specifications. · Support audits, inspections, and inspection readiness. · Coordinates the archiving of executed manufacturing records with QA Documentation Control. · Prepares batch Certificate of Compliance and Certificate of Assurance, as applicable. · Provide QA support for the electronic environmental system and the NetSuite enterprise system. This job description summarizes the primary responsibilities of the role and does not represent a complete list of all duties. Duties and responsibilities may be modified, expanded, or reassigned at any time based on business needs. Requirements Education & Qualifications: · High school diploma minimum; Associate or Bachelor’s degree preferred. · Strong knowledge of cGMP, aseptic manufacturing, and data integrity. · 5–8 years GMP experience; independent floor oversight; leads moderate investigations.

Responsibilities

Provides real-time QA oversight and independent decision-making on the manufacturing floor to ensure GMP compliance. Leads complex investigations, manages CAPAs, and reviews executed batch records and documentation.