QA Specialist role and responsibility to ensure that all documentation is systematically managed and aligned with Captek Softgel International. Our ideal candidate should have experience with Document Control, Complaint Investigations, and Review/Issuance Manufacturing Batch Records. To assure company compliance with the company SOPs, Policies and the FDA regulations for 21CFR part 110, 111 & 11.
Essential Duties and Responsibilities:
• Resolves problems and complaints in accordance with company policies and procedures.
• Responsible for handling and resolving customer complaints, completes complaint Investigations.
• Provides the information about products, addresses and solves complainant inquiries
• Ensure written replies are provided to the complainant/customer
• Attend the customer weekly meetings to address issues and follow-up.
• Provide complaint trends.
• Responsible for maintenance of company documents
• Responsible for changing, storage, and retrieval of documents for company and audits
• Able to use software skills to write, edit, revise and compare documents.
• Ensure documents meet the Captek processes and procedures, regulatory guidelines and maintain a database system for ease of document retrieval.
• Review the batch records to assure all changes have been implemented, regulatory and internal requirements are met for the product quality prior to issuing the batch records to production.
• Included is the verification of calculations associated with formulation, and overall review of documents for cGMP compliance.
• Performs other duties as assigned
• Minimum of 5 years relevant work experience
• Experience in training personnel
• Strong verbal and written communication
• Good attendance and punctuality
• Ability to follow instructions
• Excellent organizational skills/ attention to detail/ ability to work effectively in a fast-paced environment
• Strong proficiency in using Microsoft Word, Excel, Outlook and Power Point
• Effective leadership
• Ability to set priorities, be flexible, multi-task and meet deadlines
• Ability to manage time and work under pressure with minimal supervision
• Strong working knowledge of quality systems
• Minimum AA degree in health science or related discipline. Bachelor’s degree preferred. Four years of work-related experience may substitute for one year of college education.
• Working knowledge of cGMPs and FDA regulations
• ASQ CQA and/or CHA certification preferred
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.