QC Technical Services Analyst II

Lonza•Portsmouth, NH

8d•Onsite

About The Position

We are seeking an organized and detail-oriented technical professional to join our Quality organization in Portsmouth, NH, as a QC Technical Services Analyst II. This critical role directly supports the rollout of our brand-new Large Scale Allogeneic (LSA) manufacturing project by owning sample logistics, technical inventory control, and core cGMP laboratory documentation. Operating under standard supervision, you will ensure the flawless chain of custody for testing assets by managing sample receipt, specialized storage segregation, stability aliquots, and external customer or testing site shipments. Additionally, this position acts as a vital cross-functional bridge—utilizing aseptic techniques for bulk sample dispenses and governing controlled-copy printing and assay form generation to preserve right-first-time compliance for the QC testing laboratories.

Requirements

1–3 years of direct experience within a cGMP Quality Control laboratory, regulated pharmaceutical manufacturing inventory, or clinical repository setting is required.
Practical understanding of quality systems, chain-of-custody tracking, cleanroom documentation workflows, and core aseptic validation principles.
Strong sense of personal ownership, urgency, and the initiative required to drive projects to a successful conclusion.
Strong written and oral communication skills, a collaborative team-player mindset, and the professional flexibility required to manage ambiguity and adapt to shifting project prioritization timelines.
Superior time management and analytical prioritization skills; ability to make independent compliance decisions using defined internal practices, company policies, and historical data baselines.
High School Diploma or equivalent is required.

Nice To Haves

A Bachelor’s Degree in Chemistry, Computer Systems, Biology, or a related technical science field is highly preferred.

Responsibilities

Execute precise sample receipt, login, and temperature-controlled storage tracking.
Appropriately segregate clinical, commercial, and stability samples to guide rapid laboratory processing.
Manage the long-term archival placement of retain samples.
Lead annual physical inventories and coordinate structural preventative maintenance defrost cycles for stability and sample environmental chambers.
Issue controlled-copy prints of active SOPs, Test Methods, and master assay execution forms.
Coordinate periodic inventory reviews to maintain adequate bench-side stocks while archiving completed quality records.
Create, revise, and review localized cGMP laboratory documentation, logbooks, and material tracking protocols in strict compliance with data integrity regulations.
Proactively interface with cross-functional partners in Manufacturing (MFG), Supply Chain (SC), and broader Quality Control (QC) units to align sample delivery milestones with testing timelines.