Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
QA Specialist
Location: Lowell, MA
Summary of Primary Responsibilities:
The Quality Assurance (QA) Compliance Specialist performs compliance activities in support of production and engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, and ISO 9000 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and inspection/approval of incoming materials for release. The QA Compliance Specialist performs quarterly audits, supports customer and regulatory audits as part of the Audit Team. Some microbiological knowledge/experience with aseptic technique is preferred as candidate may provide some additional support to quality control testing laboratory.
Strategic Focus Area:
Effectively collaborates with internal colleagues to meet corporate objectives and drive business results.
Specific Responsibilities:
Job Complexity:
Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements.
Supervisor Responsibilities:
None
Required Qualifications:
Desired Experience, Knowledge, and Skills: