ID
#45636470
Job type
Permanent
Salary
TBD
Source
Apex Systems
Date
2022-09-11
Deadline
2022-11-09

Quality Assurance Specialist

Illinois, Chicago, 60601

Permanent

Vacancy expired!

Job#: 1281749

Job Description: Quality Assurance (QA) Specialist

Role:

The QA Specialist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility. This individual will be responsible for ensuring that manufactured products meet standards of quality, reliability, and safety.

Here's what you'll do:

Oversee the electronic Documentation, Change Control and Training system.
Implement the Quality Management System (QMS) for the organization.
Manage and oversee equipment calibration activities.
Establish Standard Operating Procedures (SOPs) and specifications for various quality and manufacturing processes.
Collaborate with the purchasing / inventory specialist to ensure raw materials from external suppliers meet quality requirements.
Establish Vendor score cards and perform supplier audits for critical vendors.
Review Production Batch Records and manage disposition of material at each step of the manufacturing process.
Collect, compile, and analyze relevant quality data and obtain information regarding quality performance.
Manage non-conformance reports (NCRs) and trend non-conforming data regarding product and processes.
Conduct quality control tests / inspections to verify quality of incoming material and finished goods.
Review existing processes, specifications, and documents and identify improvement opportunities as seen fit.

Education, Experience and Qualifications:

Minimum of Bachelor's degree in business management or administration, Biology or Bioengineering or related fields.
Previous quality assurance role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.
Excellent organizational and communication skills, with a mindset on driving quality-oriented activities.
Strong analytical and problem-solving skills.
Strong ability to collaborate with cross functional teams.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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