QA Client Representative

INCOG BioPharma Services • Fishers, IN

2d • Onsite

About The Position

The Quality Assurance Client Representative will work closely with the Sr. Manager, Quality Client Support, to ensure site compliance with Regulations, Industry Standards (e.g., ISO), and organizational SOPs. This role is crucial in championing and developing the organization’s Quality Mindset, fostering a culture of efficiency, attention to detail, and on-time delivery. The representative will support the identification and closure of Operational and Quality gaps. They are expected to possess excellent interpersonal skills, capable of building productive, customer-centric relationships with internal and external stakeholders. The role demands excellent written and oral communication skills to articulate complex issues clearly to diverse audiences. The ideal candidate will thrive in a team environment while also demonstrating strong self-management and organizational skills to work autonomously. They should value process owners and subject matter experts and be able to influence positive outcomes without direct reporting authority. INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers through a service-culture mindset, technical excellence, and a collaborative team-centered approach.

Requirements

• Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
• Minimum of 2 years of biopharma industry experience with increasing responsibilities in quality assurance.
• Excellent written and verbal communication skills.
• General computer skills evidenced by hands-on work within Microsoft software (Word, Excel, PowerPoint, etc.).
• Project management experience.
• Strong knowledge of regulatory requirements and quality standards.
• Excellent interpersonal and leadership abilities.
• Attention to detail.
• Organizational skills.
• Effective communication skills.
• Negotiation skills.
• Understanding of quality systems and technical writing.
• Ability to work independently and to remain firm in complex situations in a fast-paced environment.
• Ability to manage multiple projects in a fast-paced environment.
• Capability of developing productive, customer-centric working relationships with colleagues, internal customers, and external customers.
• Ability to clearly and concisely articulate complex issues to a range of target audiences.
• Strong self-management skills.
• Demonstrated ability influencing positive outcomes without direct reporting authority.

Nice To Haves

• Previous aseptic fill process knowledge

Responsibilities

• Lead projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations.
• Review and approve procedures, forms, deviation, specifications, and change control of moderate to high complexity.
• Perform risk assessments and take appropriate actions to ensure adequate controls related to product quality, safety, and business risks.
• Perform generation and review of quality agreements between clients and INCOG.
• Perform generation and review of customer complaints between clients and INCOG.
• Provide support during normal (8 AM – 5 PM Monday-Friday) and after business hours as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees