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$58k–$71k/yr
Full-time
associate degree, bachelor degree
Posted 22d ago
~40 hrs/week
Responsibilities
Responsible for documenting and auditing cGMP practices and developing QA procedures to ensure compliance with USFDA regulations. Acts as a liaison between the company and clients while reviewing batch production records and quality control documentation.
Requirements
Requires a BS/BA in science with 1-3 years of cGMP experience or an Associate degree with 5+ years of experience in API manufacturing. Must possess strong knowledge of ICH Q7A guidelines and experience writing GMP documents.
Full 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.
Founded in 1918, Nitto has developed our business globally to offer various products in fields such as electronics, automobiles, housing, infrastructure, environment, and medicine.
The Nitto Group strives to become a centennial company that is always trusted by customers, embraced by employees with pride, makes an active contribution to society, and continuously grows on a global scale with our slogan, “Innovation for Customers.”
Based on 2301 listings with disclosed salaries, most engineering jobs in Ohio pay between $72k–$170k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Ohio right now?
There are currently 9,887 open engineering positions in Ohio listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Ohio?
Companies currently hiring include Swagelok, GE, Amazon, Vertiv, JPMorganChase, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Ohio?
Yes — 1493 of the 9887 open engineering positions offer remote or hybrid work (426 remote, 1067 hybrid).
How do I apply for Engineering jobs in Ohio?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.