Quality Assurance Operations Specialist

2 weeks ago


New Albany, Ohio, United States PharmaForce (Ohio) Full time

Overview
This role is integral to maintaining the highest standards of Quality Assurance within designated areas by executing site policies, procedures, and operational guidelines.

Key Responsibilities
• Ensure all processes and products comply with specifications and are manufactured in line with Good Manufacturing Practices (GMP).
• Achieve and uphold qualifications for packaging lines and inspection areas.
• Conduct precise verifications and checks, including thorough process inspections.
• Perform accurate packaging AQL inspections and identify any out-of-specification products, ensuring proper segregation and escalation as necessary.
• Resolve errors and omissions in accordance with Standard Operating Procedures (SOPs).
• Document all activities in compliance with company policies, procedures, and health and safety regulations.

Additional Duties
• Oversee the release of components and raw materials.
• Monitor charts and escalate issues as required.
• Support shipping activities with quality oversight and verifications.
• Generate necessary logbooks and labels.
• Review Bills of Materials and maintain a basic understanding of cGMPs and related regulatory documents.
• Maintain qualifications for cleanroom and sterile environments, including Class A qualifications.

Qualifications
To excel in this position, candidates should meet the following criteria:
• High School Diploma or GED is required; an Associate's or Bachelor's Degree is preferred.
• A minimum of 1 year of experience in a regulated environment is preferred.
• Ability to work independently and possess intermediate skills in Microsoft Word and Excel.
• Strong organizational, interpersonal, and communication skills are essential.
• Must be receptive to constructive feedback and thrive in a collaborative work environment.
• Willingness to work overtime as needed.

Physical Requirements
Candidates must be physically capable of wearing protective cleanroom attire, including gowns, goggles, face shields, respirators, and gloves. Specific vision requirements include the ability to see 20/20 near vision (correctable with glasses or contacts) and distinguish colors. A clean-shaven appearance is necessary for the proper use of tight-fitting respirators. The ability to occasionally lift and/or move up to 25 pounds is also required.

Diversity and Inclusion
PharmaForce is committed to fostering a diverse and inclusive workplace. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

PharmaForce strives to ensure accessibility for all users. We welcome inquiries regarding the accessibility of our website and assistance with the application process.



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