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Manufacturing Jobs

QA Specialist

SpectronRx

Indianapolis, Indiana

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JOB DETAILS
SKILLS
Adobe Acrobat, Analysis Skills, Background Investigation, Communication Skills, Contract Manufacturing, Customer Support/Service, Data Collection, Detail Oriented, Driver's License, Establish Priorities, Insurance Certifications, Insurance Documentation, Internal Audit, Lift/Move 50 Pounds, Manufacturing, Mathematics, Meeting Minutes, Metrology, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Policy Implementation, Problem Solving Skills, Production Systems, Project/Program Management, Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Reconciliation, Regulations, Reporting Skills, Software Testing, Staff Training, Testing, Time Management, Workflow Analysis
LOCATION
Indianapolis, Indiana
POSTED
4 days ago
Quality Assurance Specialist
COMPANY OVERVIEW
SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. We are 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.
 
ESSENTIAL FUNCTIONS
  • 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.
  • Maintaining site documentation.
  • 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 – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
  • Attention to Detail – Ability to accurately count, verify, and record data.
  • Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
  • Speaking – Talking to others to convey information effectively.
  • Time Management – Managing own time to prioritize tasks and meet deadlines.
  • Coordination – Adjusting actions in relation to others’ actions in a team environment.
  • Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Written Comprehension – The ability to read and understand information and ideas presented in writing.
  • Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
  • Organizational Skills – Ability to maintain orderly areas and accurate records.
TRAVEL
  • Regular travel is minimal.
REQUIRED EDUCATION AND EXPERIENCE
  • High school diploma or equivalent education required.
  • Proficiency in Microsoft office (Microsoft Word, Excel, and Outlook, Microsoft PowerPoint) and Adobe Acrobat required.
  • Excellent customer service
  • Excellent communication and organizational skills.
  • Ability to train and be trained.
  • Excellent data collection and analysis skills.
  • Strong attention to detail.
  • Previous experience in quality assurance or similar field.
  • Working knowledge of tools, methods, and concepts of quality assurance.
  • Solid knowledge of relevant regulatory standards.
  • Thorough understanding of project management.
  • Excellent organizational skills and attention to detail.
PREFERRED EDUCATION AND EXPERIENCE
  • Familiarity with a manufacturing or production environment.
  • Bachelor’s degree preferred.
  • Certificate in quality assurance is a plus.
ADDITIONAL REQUIREMENTS
  • Valid Indiana driver’s license.
  • Pass a Background Check.
  • Prolonged periods of standing, walking, bending, and lifting.

About the Company

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SpectronRx

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