QA - CAPA Technical Writer - Full-time / Part-time

Aerotek is currently recruiting for a few Technical Writers to perform QA investigations for a large pharmaceutical manufacturer in the area. Candidates must have previous experience in a GMP pharmaceutical company with investigations experience.

QA CAPA Technical Writer/Investigator

This position will investigate nearly every department including QC, manufacturing, maintenance, warehouse and validations. They will spend 75% of their day interviewing people and only about 25% of their day at their desk. They are investigating the root cause of problems and the output of the investigation will be a report so technical writing skills are important.

Description:

• Impartial investigator with the ability to think critically when identifying and analyzing information accuracy, sufficiency and reliability.
• Must have the analytical ability to be knowledgeable about the subject matter, skilled in the techniques of investigation and capable of dealing with a diverse group of people.
• Sensitive to delicate circumstances/situations, and have the ability to read and assess emotions in order to accurately assess intentional or unintentional bias.
• Able to perform tedious tasks, and recognize a trivial remark or an observation could be the detail that may "crack" the case.
• Must possess the ability to confront, pursue, persist, and resist intimidation.
• Need courage to be compassionate but to tell the truth, resist pity, be independent-minded and strong in convictions and integrity. Invite and achieve voluntary cooperation by trust and the implicit promise of fairness.
• Clearly and concisely present findings in a written format that can be understood many months later by someone who only has a high level understanding of the business. The written report must demonstrate competency, understanding, and root cause in a manner that does not confuse the reader.
• Must have a desire to demonstrate excellence by setting high standards.
• Finally must possess excellent judgment to ascertain important facts from "distracting" information and to identify appropriate corrective/preventive action.
• BS/BA degree and a minimum of 3-6 years of relevant experience or a MA or MBA degree and a minimum of 4 years of relevant experience. At least 2 years of experience should be in QA.

Specific Job Requirements

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products. Approves quality investigations and determines risk to product and process. Analyzes quality-related data and generates trend reports for Management Review. May participate in the development of training programs regarding all aspects of producing quality products. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May assist compliance audits as required. May interface with contract manufacturers to address documentation and compliance issues. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

Knowledge

Must have an understanding and application of QA principles, concepts, industry practices, and standards. Assignments are routine where analysis of situation or data requires a review of identifiable factors. Develops solutions to moderately complex problems. Must be able recognize routine deviations from accepted practice. Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis. With guidance exercises judgment within well defined and established procedures and practices to determine appropriate action. Normally receives no instruction on routine work, general instructions on new assignments. Strong verbal, technical writing and interpersonal skills are required.

Specific Education and Experience Requirements

Typically requires a BA or BS degree and minimum 6 years of relevant experience in related field or a MA or MBA degree and minimum 4 years of relevant experience

Qualified candidates are encouraged to send resumes directly to Amy Nguyen.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.