QA Specialist

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.
• 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 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, high school diploma is still encouraged to apply.
• Certificate in quality assurance is a plus.

ADDITIONAL REQUIREMENTS

• Pass a Background Check.
• Prolonged periods of standing, walking, bending, and lifting.