QA Specialist

SpectronRx; South Bend (IN); On-site; USD 52,000 - 75,000; Full time

Job summary

SpectronRx is seeking an experienced Quality Assurance Specialist to join our Indiana team. The role focuses on maintaining the highest quality standards across QA activities in a cGMP environment.

You will develop and implement QA policies, perform inspections, audits, and training, and collaborate with site and corporate QA to improve processes. Strong attention to detail and communication are essential.

Qualifications

• High school diploma or equivalent required.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and Adobe Acrobat.
• 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 quality assurance tools, methods, and concepts.
• Solid knowledge of regulatory standards.
• Thorough understanding of project management.
• Excellent organizational skills and attention to detail.

Responsibilities

• Prepare and implement quality assurance policies and procedures.
• Perform routine inspections and quality tests.
• Identify and resolve workflow and production issues.
• Ensure that standards and safety regulations are observed.
• Document QA activities and create audit reports.
• Assist in internal audits and training.
• Liaise with external inspectors and QA teams.
• Oversee metrology program at the site (qualifications/validations).
• Attend quality-related meetings and interface with Corporate QA on issues.

Skills

Attention to detail

Excellent communication

Organizational skills

Data collection and analysis

Ability to train and be trained

Time management

Oral comprehension

Written comprehension

Education

High school diploma or equivalent

Bachelor’s degree preferred

Tools

Microsoft Word/Excel/Outlook/PowerPoint

Adobe Acrobat

Job description

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.