Manufacturing Compliance Specialist - Astrix Technology : Job Details

Manufacturing Compliance Specialist

Manufacturing

Fremont , CA, US

Pay Rate Low: 45.00 | Pay Rate High: 49.00

+ Added - 06/11/2024

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Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Compliance Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!

Pay: $45-$49/hr

Location: Fremont, CA

**Description** :

Manage change control records and lead projects supporting Manufacturing Operations, including monitoring and reporting deviations, change controls, and improvement projects. Own and update change control records, CAPAs, periodic reviews, and SOP revisions. Identify opportunities for continuous improvement and apply operational excellence tools to enhance efficiency.

**Experience** :

2+ years in cGMP and biopharmaceutical manufacturing, ideally as a manufacturing operator or technician.

Bachelor's degree in Biopharmaceuticals.

**Skills** :

+ Solid understanding of biopharma manufacturing, cGMP systems, and regulatory standards across regions.

+ Experience managing small to medium projects, CAPAs, and change controls, with basic knowledge of deviations, project management, and audits/inspections.

+ Proven ability to lead and maintain effective meetings and influence peers.

+ Skilled in technical writing (SOPs, protocols, deviations).

+ Strong time management, organizational skills, and multitasking abilities.

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.