Quality Assurance Specialist

SpectronRx•Indianapolis, IN

16d

About The Position

SpectronRx is a rapidly growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. 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.

Requirements

High School Diploma/GED required.
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.
Strong attention to detail.
Excellent organizational skills and 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.
Valid Indiana driver's license
Pass a Background Check.

Nice To Haves

College Degree Preferred.
Certificate in quality assurance is a plus.
Ability to train and be trained

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.
Performs other related duties as assigned.