Quality Assurance Specialist I Job at Nitto Denko, Ohio

  • Nitto Denko
  • Ohio

Job Description

About this opportunity :

As a Quality Assurance Specialist you will be responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.


Key Responsibilities:

  • Acts as departmental resource for cGMP manufacturing programs.
  • Work collaboratively with all departments to ensure manufacturing programs are delivered on time.
  • Make and act upon GMP decisions.
  • Writes, reviews and/or approves SOPs and other compliance documents for cGMP programs.
  • Reviews and authorizes batch production records and quality control documentation.
  • Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program.
  • Collaborate and interact internally to support the highest quality customer service.
  • Acts a liaison between Avecia and client with respect to compliance in cGMP manufacturing programs.
Required Skills/Abilities:
  • BS/BA in science with 1-3 years Quality Assurance cGMP experience or an Associate degree with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience.
  • High level of knowledge in cGMP guidelines as specified in ICH Q7A.
  • Experienced at writing and reviewing GMP documents.
  • Solves complex, non-routine analytical problems.
  • Very strong oral and written communication skills.


The annualized salary range for this position is between $58,100.00 - $71,100.00.

Job Tags

Similar Jobs

Department of the Air Force

Economist Job at Department of the Air Force

Job Title Job Description Duties Duties and responsibilities vary and may increase according to grade level Perform work assignments in difficulty and complexity such as evaluating data, preparing supporting documentation and presentations of analytical ...

Young World Physical Education

Interpreter (Portuguese or Spanish) Job at Young World Physical Education

 ...until filledRe-Posted: Sep 16, 2022 4:00 AM (UTC)Position Type: On Call BasisSalary: $29.07 to $29.07 per hourJob DescriptionPortuguese or Spanish Interpreter District-wide position to facilitate communication between Framingham Public Schools parents/guardians... 

Map Brewing Company

Tasting Room General Manager Job at Map Brewing Company

 ...the "Mothership" here at MAP (our affectionate nickname for our tasting room). This role is responsible for the overall leadership in our...  ...service maintain high standards for service, food quality, beer quality, cleanliness, efficiency, etc. create and maintain schedules... 

Expedite Tigers

OTR Box Truck Driver Job at Expedite Tigers

 ...OTR Box Truck DriverIndianapolis, Indiana, United States Or refer someone Job Openings OTR Box Truck DriverAbout the Job OTR Box Truck...  ...box truck lease opportunities (26ft, non-CDL) for over-the-road drivers seeking substantial income and flexibility. You'll haul loads nationwide... 

Thirty Rocks Franchisee

Junior Set Designer Job at Thirty Rocks Franchisee

 ...Job Description Job Description A set designer is in charge of designing and creating the sets that appear in films and television programmes as well as in the theatre. The role involves working with and communicating with directors, producers, costume designers and...