Location: Indianapolis, Indiana
Work Hours: Monday-Friday,
Our client has an opening for a Corporate Reference Standards Organization (CRSO) which is responsible for all corporate reference standards used by our pharmacal client.
A CRSO performs or coordinates the steps required to supply laboratories with approved reference standard materials and supporting data. Activities include specification and acquisition of source material, filling and packaging, inventory management, order fulfillment, design of analytical testing protocols, evaluation of characterization data, documentation of technical rationale for all decisions, and certification of profiles for reference standards. The result is a consistent supply of accurately defined standards which are demonstrated to be suitable for use in development and commercial global product testing applications.
Selected inventory management activities are the responsibility of a service provider through a professional services agreement. Staffing the Reference Standard Order Processing Consultant role is the responsibility of this service provider. Individuals in this role are responsible for activities such as effective interaction with global scientist, establishing and maintaining processes that protect intellectual property and confidential information, compliance with a wide variety of external regulations (FDA, DEA, DOT, IATA, Customs, etc.), and assurance of global right-to-operate through a consistent supply of reference standards.
The Consultant will also assist with receipt, material dispensing, second person verification, inventory maintenance, special security substances handling, and all associated documentation. Compliant and efficient fulfillment of reference standard orders is of utmost importance. The Reference Standard Order Processing Consultant will assure optimum fulfillment of customer needs and compliance with regulatory, safety, and other applicable regulations.
Main Responsibilities
Reference Standard Customer Order Processing
Overall ownership of the reference standard order processing system
Be the first point of contact for all issues related to reference standard orders
Process international/domestic orders (>3000 orders per year)
Extensive interaction with global customers (internal and external)
Prepare Certificate of Analysis (COA)
Assemble MSDS & other associated paperwork
Maintain customer and agency information in the database
Define & apply the appropriate business process, depending on the order type
Resource for appropriate personnel in the shipping dock to coordinate processes
Interact with appropriate personnel for the approval of external requests
Effectively interface with various customer groups to allow for positive and continuously improved interactions
Establish a relationship of trust with customers and partners
Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility and learn at every opportunity to grow ourselves through experience, training and tackling new challenges. This is what makes us Keywordians
Requirements
- Superior attention to detail, scheduling, & natural problem-solving skills
- Ability to respond to changing priorities
- Experience with the use of computers and software packages
- Teamwork and customer service-oriented mindset
- Strong communication skills, both oral and written
- Self-motivated, flexible and able to work independently
- Clerical and laboratory experience helpful
- No applicable drug allergies
- Able to accurately weigh materials with an analytical balance
- Able to stand on feet for an extended period
- Able to work in freezer conditions for brief periods
Benefits
Keywords provides all its contingent workforce with:
- Medical, dental and vision benefits
- Paid time off (including sick and select holidays)
- 401(k) enrollment with 3% employer matching
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Role Information: EN
Studio: Keywords Studios
Location: Indianapolis, IN
Area of Work: Processing
Service: Manufacturing
Employment Type: Contractor
Working Pattern: Full Time
This Organization Participates in E-Verify
Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience.
Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process.