Quality Assurance Specialist Senior

Posted 06 September 2021
SalaryNegotiable
LocationDublin, Dublin City, Leinster
Job type Contract
DisciplineScience Careers, Industrial Careers
ReferenceBBBH478645_1631009550

Job description


Title: Quality Assurance Specialist Senior

Location: Dun Laoghaire

Summary:
Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Responsibilities:
* Manage and own NC records for External Quality
* Manage and own CAPA records for External Quality
* Manage and own Change Control records internal to External Quality
* Manage and drive Quality records to closure independently
* Perform tactical batch disposition activities in support of lot release
* Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
* Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)
* Escalate risks or roadblocks to management
* Drive timely decision making using DAI principles
* Drive continuous improvements and comapny first mindset
* Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
* Own Quality record content
* Works under minimal direction
* Identify opportunities and issues, then determine when escalation is necessary
* Proposes revisions to SOPs in area of responsibility

Qualifications and Experience:
* Doctorate degree OR
* Master's degree & 2 years of directly related experience OR
* Bachelor's degree & 4 years of directly related experience OR
* Associate's degree & 10 years of directly related experience OR
* High school diploma / GED & 12 years of directly related experience
* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor's Degree in a Science Field
* cGMP Experience
* Ability to oversee multiple projects simultaneously
* Able to successfully manage workload to timelines
* Familiarity with basic project management tools
* Ability to negotiate a position after taking feedback from multiple sources
* Demonstrated ability to consistently deliver on-time, and high-quality results
* Ability to operate in a matrixed or team environment
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
* Ability to travel +/- 10% of time to domestic and international sites.

Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.

As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.