Aerotek Quality Assurance Specialist in Gaithersburg, Maryland
Quality Assurance specialist position is responsible for performing quality functions such as implementing and monitoring the GMP related activities to ensure they are incompliance with the Quality Management System (QMS) and Regulatory Agency (FDA) requirements. The candidate shall have good knowledge and understanding of the relevant GMP regulations and shall have the required working experience in a GMP manufacturing environment. The candidate shall be a result-oriented self-starter with good communication skills and a commitment to teamwork and reliability.
The main responsibilities will include but are not limited to:
Preparing/authoring and implementing quality assurance policies and procedures. Ensuring that the GMP activities are in compliance with the QMS and Regulatory requirements by performing internal audited and implementing and evaluating the CAPA program. Conduct reviews of Quality documents and records e.g. SOPs, Batch Record, Quality Control documents and test data, validation protocols and reports, lab notebooks etc. Perform lot disposition function. Perform Vendor audits and evaluate CAPA plans as required. Perform QA on the floor activity. Represent Quality during investigation of deviations, OOS, quality incidences etc. and evaluate CAPA plans. Approve related documents and reports. Deliver Quality Management Systems (QMS) training for employees such as, New Hire Orientation Training, Good Documentation Practices, Investigation of Quality events, etc. Any other duties and function related to maintenance of QMS as required by the management.
batch record review, capa, Quality Assurance, QA, GMP, Audit, Document Management, Vendor Oversite, Compliance, Product Release
Top Skills Details:
Quality Assurance GMP Compliance QMS Audit
Additional Skills & Qualifications:
BS in the life sciences e.g. Biochemistry, Chemistry, Chemical Engineering, Biology, related field.
Minimum 4-6 years of hands-on experience in performing GMP quality compliance functions.
Ability to apply scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
Must have strong organizational skills and an ability to handle track and execute multiple priorities
Highly motivated, with willingness to acquire new skills and ability to learn quickly
Strong engineering/scientific understanding, and ability to apply knowledge to process development
Detail oriented, good documentation practices, technical writing and verbal communication skills
Possess strong problem solving and analytical skills and be an independent and creative thinker
Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
Interpersonal and leadership skills to work with teams in different functions and organizations
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.