GCS Document Specialist at American Cybersystems, Inc. in New Haven, Connecticut

Job Description:

Innova Solutions is immediately hiring for a Supply Chain Planning Analyst


Position type: Full-time Contract

Location: (Remote)

Duration: 12+ Months


Note:

• Supply chain planning, shipment documentation experience
• Vendor form and quality investigation
• Must have clinical supply experience

As aSupply Chain Planning Analyst, you will:

Day-to-day Operations

1. Collaborate with CSMs on maintenance of GCS operations-related documents for all active and upcoming studies (list below)
• Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc
2. Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents
3. Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
4. Interface with internal functions and external vendors to obtain and maintain GCS study documents generated in day-to-day GCS operations
5. Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement

Inspection Readiness Support

1. Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors' requests
a. Typically documents not already in BOX study folders
2. Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections
3. Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports

Potential Areas of Support

1. Act as the GCS POC for document storage transition from BOX and OneDrive
2. Create and maintain GCS documents in Vault, the GMP environment
3. Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa

Key GCS study documents:

Packaging/Labeling/Distribution:

• Request for Packaging (Blinded and Unblinded RFP), Variable Data Request, Label Links and Rand, Packaging Specifications (PS), Certificate of Compliance/Conformance (CoC), Certificate of Analysis (CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release Certificates, Global Distribution Specifications (GDS), Drug Return Instructions (DRI), Certificate of Destruction (CoD)

IRT:

• IRT specifications (Endpoint PULSE and Almac IXRS), Endpoint DRIVE Specifications, User Acceptance Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change
• Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate
• Audit trail report requests for site/user changes for audits and inspections

Study Maintenance:

• Study Protocol, Pharmacy Manual (PM), Vendor Oversight Plan (VOP- GCS and study-level), Meeting Minutes, Purchase Order (PO) requests, Clinical Supply Agreement (CSA)
• Quality (with GCSQ and external QA): Vendor Deviation Reports

Note:

• Supply chain planning, shipment documentation experience
• Vendor form and quality investigation
• Must have clinical supply experience

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Shakir Ahmed
Sr. Recruiter
PHONE (208-620-3493)
EMAIL (shakir.ahmed@innovasolutions.com)

PAY RANGE AND BENEFITS:

Pay Range*: Pay Range: $64 - $66 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. Apply Now