Serialisation Administration Support
100% US Remote
Initial 12-month contract (likely extension or conversion at that time)
We are exclusively partnering with a key account as they look to introduce a NEW role into the US market, being the Serialisation Admin Support. This role will partner closely with the Senior Manager, Global Serialisation and be the very first team member for this division in the US.
With the guidance of the Senior Manager, this individual will ensure the 3PL ICS and all outbound wholesalers are supplied with Serialisation data for products in support of the batch release, to provide support with serialisation track and trace for all markets as well as vendor management, system validation, and issue resolution.
Successful candidates will come from a strong quality background incl. batch records and package manufacturing skills. If you have experience within track and trace, within the biotech/pharma market, we want to hear from you!
- Make sure all market Master Data (MD) updates are on track with agreed trade routes, in a time-efficient and accurate manner.
- Ensuring the required parties are correctly supplied with Serialization data for US and ROW products, in support of batch release under EU FMD and DSCSA.
- Establish close working relationships with various CMO MD teams, ensuring Serialization Master Data is shared accurately and on time.
- Assist with the development and update of all serialization procedures.
- Co-ordinate and manage communication with the serialization service provider: Covectra
- Ensure a smooth vendor management environment (Covectra, rfxcel etc)
- Oversee the end-to-end Serialization process from manufacturer to 3PL ICS onto all wholesale partners and comply with master data requirements.
- Managing and co-ordinating of resolution alerts through to completion, raise and follow up on CAPAs as an outcome of an issue/alert/query.
- Develop & maintain a roadmap of the global serialization program relevant to the client's portfolio/markets.
- Complete transactions on a batch-by-batch basis to ensure the required serialization data is transferred to the correct repository in support of batch release (including the completion of documentation to verify successful data transfer to the releasing QP)
- Manage the information provided from the market such as investigation of suspect packs, scanning issues at the point of dispensing, and managing documents to completion within the IND systems.
- Manage admin requirements for all serialization vendor creations & maintenance including serialization for the following: contract updates, purchase order creation, invoice approval & tracking, and vendor communication (non-technical)
- Bachelors degree
- Min. 4yrs in a Quality role within a manufacturing setting.
- Prior experience liaising with CMOs and outside vendors.
- Knowledge or understanding of serialization/track and trace.
- Experience working in an admin support role in the pharmaceutical industry.
- Previous experience maintaining and organizing serialization records to demonstrate complaisance.
BACKGROUND / SKILLS REQUIRED (PLUS):
- Experience with structuring and updating serialization databases/systems.
- Level 4 Serialization systems (rfXcel/Tracelink/Covectra).
- Knowledge of pharmaceutical supply chain/quality environments with knowledge of NMVS Alerts portal, EMVS, NMVO’s and national requirements under EU FMD.
$50 - 60/hr (*On a W2 Model*)
$65 - 75/hr (*On a 1099 Model*)
*Based on experience, relevant to the role*
Job Type: Contract
Pay: $50.00 - $80.00 per hour
- Dental insurance
- Health insurance
- Vision insurance
Weekly day range:
- Do you have experience with TrackWise?
- Do you have experience within a CMO environment?
Work Location: Remote