QA Specialist I

JOB SUMMARY

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

PRIMARY DUTIES AND RESPONSIBILITIES

• Review/release analytical data for conformance to regulatory, company, and customer requirements.
• Alternate contact person for QA questions relating to laboratory operations and client correspondences.
• Review laboratory protocols and reports for accuracy and compliance to cGMP s, as applicable.
• Verifies data for GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components) was reviewed and approved by appropriate SMEs.
• Review and approval of documents and data associated with the Stability Program.
• Other assigned responsibilities as established by the Quality Assurance Lead.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a Bachelor s degree in a related science discipline with 0-3 years of QA experience, preferably in a pharmaceutical industry.

MINIMUM SKILLS REQUIREMENTS

• 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.