Quality Assurance Associate

⚡ Job Title: Quality Assurance Specialist

📍 Location: 100% Onsite New Albany, OH; 43054 (should not exceed one hour commute distance)

⏳ Duration: 1 year minimum

🕗 1st shift, 8 AM – 5 PM, Monday through Friday

⏱️ Overtime: Possible during project peaks; no fixed schedule established.

📌 Description:

• The ideal candidate is a detail-oriented Quality Assurance professional with at least 2 years of GMP experience in a regulated manufacturing environment, preferably within pharmaceuticals or medical devices.
• They should bring a solid understanding of QA documentation processes, including change controls, equipment qualifications, and master data approvals, and be comfortable working within SAP or EPR systems.
• Strong project coordination skills and organizational discipline are essential, as this role supports a large-scale product launch and will require managing multiple deliverables on tight timelines.
• A background in process development, manufacturing, or digital quality innovation is highly desirable.
• Candidates should be local to New Albany, Ohio, or within approximately an hour’s commute.

📌 Preferred Qualifications:

• Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
• Experience managing projects through to completion meeting timelines
• Evaluating documentation and operations according to company procedures
• Experience working with Quality Systems
• Strong organizational skills and ability to manage multiple tasks at one time
• Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives

📌 Top 3 Must Have Skill Sets:

• Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Affinity with digital innovation, data sciences and Quality engineering
• Highly effective verbal and written communication skills, strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

🧠 Day to Day Responsibilities:

• This position supports Client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas.
• Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems.
• Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion.
• The QA Specialist will also represent QA Functional area in the execution of projects necessary to achieve departmental operational goals.