Overview
Quality Assurance Associate Specialist Jobs in St. Louis, Missouri, USA at MilliporeSigma
Location: St. Louis
Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLM Maintenance, Engineering
Hiring Manager: James Crouch
This information is for internals only. Please do not share outside of the organization.
Your Role
The Specialist’s primary role is to provide support to the Engineering, Facilities and Maintenance Department at the St. Louis sites. This position is responsible for assisting with quality support as it relates to change control, equipment and process deviations, departmental corrective and preventative actions, audit response and routine equipment system maintenance. This position will reside in an office setting. Limited travel may be needed for training and auditing purposes.
This position is based in St. Louis at 3050 Spruce St.
Responsibilities:
Coordinate documentation and tasks associated with equipment and facilities:
Change management, New Equipment additions, Preventative maintenance, Calibration, Deviations and CAPAs
Track and report progress of quality events to management and department impacted
Assist with equipment, facility and process investigations, trouble-shooting including root cause analysis
Maintenance of quality systems and applicable ISO standard and regulatory compliance
Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
Assist with documentation and record pull associated with the Facilities, Engineering and Maintenance department during internal and external audits
Assist in the generation of manufacturing CAPA, deviation and change control trend reports
Who You Are
Minimum Qualifications:
High School Diploma or GED
1+ years of experience in a role supporting quality initiatives
OR
Associate degree in any discipline
1+ years of experience in a role supporting quality initiatives
Preferred Qualifications:
2+ years of experience supporting/working in an ISO or GMP environment
Strong computer and document management skills.
Demonstrated ability to work within a cross-functional team
Effective oral and written communication skills
Effective, disciplined, and demonstrated documentation skills
Ability to understand regulatory requirements such as ISO 13485 and GxP
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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Title: Quality Assurance Associate Specialist
Company: MilliporeSigma
Location: St. Louis, Missouri, USA
Category: Quality Assurance – QA/QC, Engineering
