Amgen currently has a vacancy for those looking to work as a Amgen Job Openings – Senior Associate Quality Assurance for Full Time at their offices in West Greenwich, RI, US. Applicants should be sure to read the job outline attentively if they intend to apply.
|Job Title:||Amgen Job Openings – Senior Associate Quality Assurance||Company Name:||Amgen||Job Location:||West Greenwich, RI, US||Job Type:||Full Time||Job Category:||Amgen||Job Link Expiry:||2023-12-30||Posted on:||Jobinton.com|
The Plant Quality Assurance team shift structure aligns with Manufacturing, which is a 12-hr rotating shift work schedule. For this specific day shift role, the shift pattern will be a 7AM – 7PM structure with a rotation that offers an average of 14 days on shift per month with every other weekend off.
- Complete required assigned training for self to permit delivery of required tasks.
- Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
- Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
- Ensure facilities, equipment, materials, organization, processes and procedures align with cGMP practices and other applicable regulations.
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
- Perform training activities, as needed.
- Support management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.
- Audit and inspection support.
- Support operational improvement initiatives, programs and projects.
- Assess changes that could potentially impact product quality.
- Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
- Lead all aspects of and provide guidance during on-the-floor analytical testing.
- Ability to follow assignments through to completion and meet timelines
- Strong technical communication skills, both written and oral
- Strong word processing, presentation, database and spreadsheet application skills
- Strong cGMP and GDP behaviors
- Exposure to regulatory agency inspectors or participation in regulatory agency audits
- Demonstrated ability to work as a great teammate and independently
- Strong organizational skills and ability to manage multiple tasks at one time
- Knowledge of electronic systems including LIMS, Trackwise, and Maximo
- Demonstrated experience with deviations and CAPA records
- Previous experience supporting GMP testing laboratories
Qualification & Experience:
- Associate’s degree and 6 years of Quality experience OR
- Master’s Degree OR
- Bachelor’s Degree and 2 years of Quality experience OR
- High school diploma/GED and 8 years of Quality experience
Vacancy Type: Full Time
Job Location: West Greenwich, RI, US
Application Deadline: N/A