QA Client Representative

INCOG BioPharma Services; Fishers (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Quality Assurance Client Representative to support site compliance with regulations, industry standards, and SOPs. You will champion a quality mindset and help identify and close operational and quality gaps while partnering with internal and external customers.

Required: a Bachelor’s degree in a related science and at least 2 years in biopharma QA, plus excellent written and verbal communication.

Qualifications

• Bachelor’s Degree in a related Science required.
• Minimum of 2 years of biopharma QA experience with increasing responsibilities.
• Excellent written and verbal communication skills.
• General computer skills evidenced by hands‑on work within Microsoft software.

Responsibilities

• Leads projects of moderate complexity, conducting compliance assessments and drafting new procedures.
• Reviews and approves procedures, forms, deviations, specifications and change controls of moderate to high complexity.
• Performs risk assessments and implements controls related to product quality, safety and business risks.
• Project management experience and ability to manage multiple projects in a fast-paced environment.
• Strong knowledge of regulatory requirements and quality standards.
• Provides clear written and oral communications and can influence outcomes without direct reporting authority.

Skills

Quality mindset

Regulatory knowledge

Project management

Communication

Team collaboration

Self-management

Education

Bachelor’s degree in a related Science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Working closely with the Sr. Manager, Quality Client Support, the Quality Assurance Client Representative will be instrumental in ensuring site compliance with Regulations, Industry Standards (e.g. ISO), and organizational SOPs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The Quality Assurance Client Representative will provide support with identifying and closing Operational and Quality gaps.

The Quality Assurance Client Representative will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external customers. The Quality Assurance Client Representative will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Quality Assurance Client Representative will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Quality Assurance Client Representative will value process owners and subject matter experts and will possess a demonstrated ability influencing positive outcomes without direct reporting authority.

Essential Job Functions:

• Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures and ensuring adherence to current regulations

• Responsible for reviewing and approving procedures, forms, deviation, specifications and change control of moderate to high complexity

• Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety and business risks

• 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, and understanding of quality systems and technical writing

• Ability to work independently and to remain firm in complex situations is required in this fast‑paced environment

• Perform generation and review of quality agreements between clients and INCOG

• Perform generation and review of customer complaints between clients and INCOG

• Ability to manage multiple projects in a fast‑paced environment

• Provide support during normal (8 AM – 5 PM Monday‑Friday) and after business hours as needed

Special Job 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 are evidenced by hands‑on work within Microsoft software (Word, Excel, PowerPoint, etc.).

Additional Preferences:

• Previous aseptic fill process knowledge

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world‑class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long‑term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full‑time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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