QA Specialist

SpectronRx; Bunker Hill (IN); On-site; USD 58,000 - 75,000; Full time

Job summary

SpectronRx is seeking an experienced QA Specialist in Indiana to help maintain quality standards across production and QA processes. The role involves preparing QA policies, performing inspections, auditing materials, and coordinating with site and corporate QA teams.

Candidates should have a high school diploma (QA certificate preferred), strong data analysis skills, and proficiency with MS Office and Adobe Acrobat. Willingness to train and train others is essential, with minimal travel.

Qualifications

• High school diploma or equivalent required.
• Proficiency in Microsoft Word, Excel, Outlook and Adobe Acrobat.
• Excellent communication and organizational skills.
• Ability to train and be trained.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Working knowledge of quality assurance tools and concepts.
• Solid knowledge of relevant regulatory standards.
• Excellent organizational skills.

Responsibilities

• 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.
• Documenting quality assurance activities and creating audit reports.
• Preparing documentation for batch production and QC.
• Material acceptance and creation of material specification sheets.
• Oversee examination and evaluation of incoming material against specs.

Skills

Quality assurance

Attention to detail

Communication

Time management

Organizational skills

Education

High school diploma

QA certificate

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Adobe Acrobat

Job description

SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana 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 meticulous 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.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Solid knowledge of relevant regulatory standards.
• Excellent organizational skills and attention to detail.

PREFERRED EDUCATION AND EXPERIENCE

• Familiarity with a manufacturing or production environment.
• Previous experience in quality assurance or similar field.
• Certificate in quality assurance is a plus.

ADDITIONAL REQUIREMENTS

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

ADDITIONAL INFORMATION/BENEFITS

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process.
• We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.