Quality Assurance Specialist

Company: Aerotek
Location: Garland
Posted on: February 18, 2021

Job Description:

Description:Shift: M-F 8AM - 5PMThe QA Specialist will assist the QA Manager and will focus on continuous improvement of the quality program, including but not limited to the following: Provide direction and lead the development and implementation of quality systems that meet company, customer and regulatory requirements. Interact with management and other personnel to coordinate the activities of Quality Assurance with those of other departments within the company Create, revise & approve Standard Operating Procedures Create Quality System documents (Non-conformance reports, Deviations) as required. Conduct investigations to closure on supplier non-conformances. Interact with suppliers on quality issues and specifications. Conduct investigations to closure on customer complaints. Interact with customers on quality issues and specification. Conduct internal audits to ensure compliance within company procedures and cGMPs (contract good manufacturing practices) Support development of continuous quality improvement programs. Assist with inspections by regulatory authorities. Review and approve production documentation and specifications to ensure compliance with Company and regulatory requirements. Coordinate the Corrective and Preventative Action Program, perform investigations, prepare investigation reports, and review. Maintain quality system reports and prepare quarterly reports for Senior Management.Track and Trend quality data and report to management. (via MS Office & Excel)Skills:Quality assurance, Qa, Gmp, Sop, Capa, Supplier quality, Quality control, Chemistry, Biology, Batch record review, writing SOPs, Chemical API, FDA, EPATop Skills Details:Education B.S. in Chemistry or related scientific disciplineExperience 2 years direct work experience in a regulated Quality Assurance department in a regulated manufacturing plant. Working under cGMP (contract good manufacturing practices) Pharma/Medical Device/Chemical API (preferably) Understanding of regulatory bodies; EPA & FDASkills: Highly proficient in writing, reviewing, and editing using Microsoft 365 Word Strong leadership skills Willingness to work in production as needed to assist with the improvement of manufacturing techniques and equipment.Additional Skills & Qualifications:This person needs a basic understanding of Quality Assurance as it related to a chemical manufacturing plant. Could have a sciences degree and 2 years working with SOPs and customer complaints. Everything else will be trained on the job.Experience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Garland , Quality Assurance Specialist, Other , Garland, Texas