Quality Assurance Specialist

QA Specialist
Quality Assurance Specialist

We are looking for a detail-oriented Quality Assurance Specialist to assist the Site QA and Corporate QA in the site’s Quality Assurance activities. To be successful as a Quality Assurance Specialist, you should be incredibly thorough and able to help our company maintain the highest quality standards.

Quality Assurance Specialist 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.
• 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.

*The above represent the minimum job expectations and are subject to change.

Quality Assurance Specialist Requirements:

• High school diploma/GED required.
• Degree preferred.
• Certificate in Quality Assurance is a plus.
• Previous experience in Quality Assurance or similar field.
• Working knowledge of tools, methods, and concepts of Quality Assurance.
• Proficiency in Microsoft Office Applications.
• Solid knowledge of relevant regulatory standards.
• Good communication skills, both verbal and written.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals or technical procedures.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to solve problems and effectively communicate in-person and on the phone.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.

Must be authorized to work in the U.S.

Job Type: Full-time

Pay: $25.00 - $32.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Holidays
• Monday to Friday
• Night shift
• On call
• Weekends as needed

Application Question(s):

• We may require, as needed, individuals to have availability past normal working hours. Is this something you can do?

Education:

• Associate (Preferred)

Experience:

• Quality Assurance: 2 years (Preferred)
• pharmaceutical: 1 year (Preferred)

Ability to Commute:

• South Bend, IN 46635 (Required)

Work Location: In person