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
Qualifications include a Bachelor’s degree in a related science discipline with 0-1 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.