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. - 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.
- 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.
- Valid Indiana driver’s license.
- Pass a Background Check.
- Prolonged periods of standing, walking, bending, and lifting.
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