- 179230 - Quality Specialist/Technical Writer
- 11 Months
- Chipton-Ross is seeking a Quality Specialist/Technical Writer for an opening in Rockville, MD.
Our company seeks a Technical Writer and Investigator responsible for site support and coordinating investigations and responding to Quality Management System Deviations and Complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence. This role conducts in-depth interviews to obtain and document accurate information. Then composes written technical concepts in a clear and concise manner to enable clients to analyze product impact and ensure prevention of reoccurrence. Additionally, this role completes CAPAs and effectiveness checks within the Quality Management System. It also establishes recommendations for changes to Standard Operating Procedures (SOPs) and associated documentation. The individual will work independently or as a part of a team in the completion of assigned tasks, often without constant supervision. This role supports both internal and external audits as a Subject Matter Expert (SME) and serves as departmental resource for technical advice for special projects as well as daily floor issues.
• Conducts all activities in a safe and efficient manner.
• Applies Good Manufacturing Principles (GMP) in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs the following duties through guidance from the Area Director of Operations and Site Leaders.
• Composes technical concepts in a clear and concise manner to enable clients to analyze product impact and ensure prevention of reoccurrence.
• Investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence.
• Conducts in-depth interviews to obtain and document accurate information.
• Effectively completes CAPAs and effectiveness checks within the Quality Management System.
• Establishes recommendations for changes to Standard Operating Procedures (SOPs) and associated documentation (i.e. protocol risk assessments).
Other duties may be assigned to meet business needs.
• Must be able to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.
• Experience in Microsoft Suite (i.e. Excel, Word, PowerPoint).
• Ability to read and interpret GMP and other regulatory requirements.
• Ability to work effectively and accurately in a fast-paced environment.
• Must possess the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Must be able to utilize Root Cause Analysis techniques to identify and describe (write) the root cause and critical contributing factors to the event.
• Must be able to work with subject matter experts to identify and document the Corrective and Preventative actions (CAPA) that will minimize the risk of a repeat occurrence of the event.
• Must be able to effectively interact with internal contacts at all levels company-wide (IT, QA, Operations, Client Services, Supply Chain, etc.). Limited contact with external customers.
• Must have the ability to effectively present information and respond to questions from senior management, peers, and clients.
• Able to work independently and in a team environment
• Strong written and verbal communication skills.
• Excellent prioritization skills.
• Task and detail oriented.
• Independent problem solver.
• Ability to multi-task/manage multiple projects and strong ability to drive tasks/projects to closure by project deadline.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
• College degree and 2-4 year experience working in a Pharmaceutical/GMP environment.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.