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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Skills Required
- Bachelor's degree
- At least 2 years of biopharma industry experience with increasing responsibilities in quality assurance
- Excellent written and verbal communication skills
- General computer skills and hands-on experience with Microsoft Word, Excel, and PowerPoint
- Previous aseptic fill process knowledge
- Authorization to work full-time in the United States without employer sponsorship
What We Do
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we will offer customized packaging services to include labeling, device assembly, final packaging and integrated storage solutions at various temperature conditions.
