Quality Assurance Specialist I

Avecia Pharma; Cincinnati (OH); On-site; USD 58,100 - 71,100; Full time

Job summary

A chez Avecia Pharma, the Quality Assurance Specialist will document and audit cGMP practices across the site, developing and revising QA procedures to strengthen cGMP compliance per USFDA Title 21 CFR Part 210, 211 and ICH Q7 guidance.

Key responsibilities include coordinating with departments to meet GMP requirements, approving SOPs, and ensuring batch records and QC docs meet quality standards. The role emphasizes liaison with clients and cross-functional collaboration.

Qualifications

• BS/BA in science with 1–3 years QA cGMP experience or an Associate degree with 5+ years QA cGMP experience in API manufacturing or related industry.
• High level of knowledge in cGMP guidelines as per ICH Q7A.
• Experience writing and reviewing GMP documents.
• Strong problem solving for non-routine analytical issues.
• Excellent written and verbal communication skills.

Responsibilities

• Act as departmental resource for cGMP manufacturing programs.
• Collaborate with all departments to ensure programs are delivered on time.
• Make and act upon GMP decisions.
• Write, review, and approve SOPs and other compliance documents for cGMP programs.
• Review and authorize batch production records and QC documents.
• Set up and track material flow and labeling to ensure cGMP compliance.
• Liaise between Avecia and clients regarding cGMP compliance.
• Support highest quality customer service through internal collaboration.

Skills

cGMP QA knowledge

GMP documentation

Analytical problem solving

Communication skills

Education

BS/BA in science

Associate degree in related field

Job description

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.