Quality Assurance Specialist

Spectron Rx is a rapidly growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. We seeking an experienced QA Specialist to join our growing company. To be successful as a Quality Assurance Specialist, you should be incredibly thorough and able to help our company maintain the highest quality standards.

• Preparing and implementing quality assurance policies and procedures.
• Performing routine inspections and quality tests.
• Identifying and resolving workflow and production issues.
• Ensuring that standards and safety regulations are observed.
• Addressing and discussing issues and proposed solutions with superiors.
• Documenting quality assurance activities and creating audit reports.
• Preparing documentation and materials required for batch production and QC.
• Material acceptance and creation of material specification sheets.
• Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
• Maintain employee training binders.
• Assist Site and Corporate QA in internal audits and making recommendations for improvement.
• Creating training materials and operating manuals as requested by Site and Corporate QA.
• Liaise with external inspectors, CMO representatives, particularly on QA-related topics and take minutes of meetings, if requested.
• Assist in the oversight of the metrology program at the site. (equipment/personnel qualifications/validations, etc.)
• Assist as required with all other site QA activities not otherwise listed above.
• Attend quality related meetings and conference calls. Interface with Corporate QA on quality related issues. Provide any status updates as required by Corporate QA.
• Performs other related duties as assigned.

• Physical Ability – The position is primarily sedentary.
• Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
• Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Speaking - Talking to others to convey information effectively.
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Time Management - Managing one's own time and the time of others.
• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
• Coordination - Adjusting actions in relation to others' actions.
• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
• Written Comprehension – The ability to read and understand information and ideas presented in writing.
• Written Expression - The ability to communicate information and ideas in writing so others will understand.
• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
• Certificate in quality assurance is a plus.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Proficiency in Microsoft Office Applications.
• Solid knowledge of relevant regulatory standards.
• Excellent organizational skills and attention to detail.
• Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals or technical procedures.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to solve problems and effectively communicate in-person and on the phone.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
• Ability to train and be trained