Gxp Qa Specialist Jobs in California

Proficiency in MS Office suite and database management, and preferably experienced with SAP S/4 HANA and Power BI.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Minimum of 2 years of medical device quality or equivalent experience in FDA regulated medical device manufacturing environment(s).

Knowledge of QSR and ISO 13485.

Excellent communication skills, both written and verbal

Develop quality plans for site projects

QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).

Performs a variety of activities to ensure compliance with applicable regulatory requirements.

Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations

Demonstrates audit and investigation skills, and report writing skills.

Demonstrates strong verbal, technical writing and interpersonal skills.

Prior experience in pharmaceutical industry is beneficial.

Knowledge of IMAC, SLA's and Asset management, ITIL

Inventory control and asset management

Manage and maintain relevant SOPs and other documentation e.g., Knowledge Base articles following GxP, GmP and GDP practices.

At least 2 years of working experience in information technology. Excellent knowledge of English language (written and spoken).

Manage and maintain relevant SOPs and other documentation e.g., Knowledge Base articles

Support Users Remotely utilizing teams, Bomgar or Remote desktop.

Bachelor's degree preferred with 1 to 2 years of quality experience in medical devices.

Will consider an associate's degree but MUST have at least 2 to 4 years of quality experience in medical devices.

General exposure to quality systems is needed. - More than 4 yrs. of experience will be overqualified for this role.

Quality Experience in Med device

They are not investigating the complaint and just making sure it is properly documented.

Need to have Quality med device exp.

2 + years of experience with quality management.

?Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.

Advanced knowledge of English (written and spoken)

Implement quality standards, ensure and execute compliance on every stage of the process.

Ensures compliance and gives recommendations.

Facilitates audits and regulatory inspections.

Applies general knowledge of business developed through education or experience and begins to learn Neurocrine's business

Records, resolves, and tracks product complaints in Neurocrine’s product complaint management system

Triages incoming complaints and escalates critical complaints to Management

Knowledge of quality systems and regulatory compliance requirements for cGMP and/or GLPs.

Developing skill and abilities with tools used in the job family or discipline

Monitors complaint records, manages communication and follow-up of complaints to ensure timely complaint closure