Quality Assurance Specialist

The Quality Assurance Specialist supports the QA Lead and the company’s quality program by auditing chemists analytical data, routine work, protocols and reports.

Primary Duties and Responsibilities:

• Review/release routine project folders for conformance to regulatory, company, and customer requirements.
• Review and approve Standard Operating Procedures (SOP’s, Forms and Methods) and familiarity with internal SOPs.
• Alternate contact person for QA questions relating to laboratory operations.
• Review laboratory protocols and reports for accuracy and compliance to cGMP’s, as applicable.
• Review and approval of data for determining the disposition of GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the Stability Program.
• Other assigned responsibilities as established by the Quality Assurance Lead.

Requirements:

Qualifications include a Bachelor’s degree in a related science discipline with 0-1 years of QA experience, preferably in a pharmaceutical industry.

• Knowledge of GMPs related compliance regulations and guidances are required.
• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, analytical, verbal communication and technical documentation skills.
• Good computer skills, such as MS office software.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.

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