Company Description
CalCog, Inc. is a trusted clinical supply services partner supporting global clinical trials from early- to late-phase development. Specializing in complex and blinded trials, cold chain logistics, and Schedule I–V investigational product management, CalCog delivers end-to-end clinical supply solutions. The company emphasizes operational excellence, trusted expertise, and agile team practices to ensure clinical supply programs are precise, compliant, and on schedule. With a focus on optimizing clinical supply chains, CalCog fosters sustainable growth by building long-term client partnerships. Join a team dedicated to advancing global clinical trials through precision and transparency.
Role Description
This remote, full-time role is for a Clinical Packaging Documentation Technician who will be responsible for generating batch records and designing clinical labels to support packaging and labelling operations. This role plays a critical part in ensuring compliance, accuracy, and operational readiness, and directly impacts clinical trial timelines. This position is well suited to an individual who thrives on detail, enjoys working in a GMP-regulated environment, and is looking to grow within clinical supply.
Clinical Batch Records
* Prepare cGMP-compliant clinical packaging batch records in line with internal procedures
* Develop in-process steps based on SOPs, Statements of Work (SOW), packaging specifications, and client requirements
* Incorporate study-specific requirements such as blinding and complex kit assembly
* Define and implement in-process controls (line clearance, reconciliation, equipment checks)
* Populate and verify batch-specific data (lot numbers, expiry dates, kit ranges)
* Track, reconcile, and archive documentation in accordance with cGMP requirements
Clinical Label Design & Management
* Design and generate clinical trial label proofs in compliance with 21 CFR Part 311 and 21 CFR Part 312
* Manage artwork review and approval workflows to support timely print release
* Collaborate with Quality, Compliance, and clients to define label content
* Maintain label specifications, version control, and traceability
Communication & Cross-Functional Support
* Support deviation investigations and CAPAs
* Assist with audit and inspection readiness
* Communicate documentation status and proactively escalate risks
* Identify and support process improvement initiatives
* Collaborate effectively across departments
* Ensure all activities comply with SOPs and applicable GxP requirements
* Maintain confidentiality and protect company and client information
* Complete required training within defined timelines
* Perform additional duties as required to support business needs
Qualifications
* 3+ years of experience in batch record writing or preparation within a GMP environment
* Bachelor’s degree, or equivalent experience, in a relevant field
* Working knowledge of clinical labelling regulations and/or label design experience, preferred
* Strong attention to detail and organizational skills
* Ability to manage multiple concurrent studies and deadlines
* Proactive, collaborative approach to teamwork
* Experience working remotely in a similar role
* Proficiency in Microsoft Office (Word, Excel, Outlook)
* Ability to work both independently and within a team environment
* Flexible, motivated, and detail-oriented mindset
* Experience with Loftware Prisym 360 is a plus