Christopher Gilbert Email & Phone Number

San Francisco, Ca, Us

Formerly Ikaria, Inc.

▪ Responsible for maintaining accountability and efficiency of the enterprise quality management system (QMS)▪ Use problem-solving strategies to identify, resolve, and prevent issues in the QMS including mitigating program bugs, as well as solving user issues on a daily basis▪ Develop and maintain metrics to quantify and qualify QMS processes on a quarterly basis for management review▪ Revise outdated Standard Operating Procedures (SOPs), as well as author new SOPs, work instructions, forms, etc. for all employees from Critical Care division of company to adhere. Work cross functionally with process stakeholders to achieve buy-in for new processes in documents.▪ Train QA team members on essential duties in facilitating document and change control processing and procedures▪ Employ a systematic approach to problem solving and root cause identification▪ Highly proficient system administrator in MasterControl QMS, extremely flexible in application of skillset to other QMS programs▪ Successfully integrated five acquired businesses’ 30,000+ collective documents into Mallinckrodt’s QMS▪ Created infrastructure to support efficient identification and retrieval of documents and records from legacy businesses▪ Integrated and trained 200+ users from legacy businesses into Mallinckrodt’s document and change control processes

Formerly Ikaria, Inc.

▪ Managed change control process for GxP IT changes▪ Prepared documents (SOPs, forms, manuals, policies) for confidential viewing of information by third party entities and regulatory agenciesQMS System Upgrades/Computer Systems Validation▪ Authored and executed IQ’s and PQ’s for system validation testing of two separate version upgrades to QMS▪ Performed QA duties for validation of GxP and non-GxP IT systems, including reviewing/approving test scripts, Risk Assessment, developing Trace Matrix, etc. New Documentation Process Development ▪ Developed and cross-functionally socialized new document workflow processes within QMS, improving efficiency in workflows for product as well as QSR documentation, and enhancing user experience ▪ Trained 300+ employees in-person and remote on new processes; conducted follow-up training by developing quizzes to confirm user understanding▪ Facilitated document workflow routing in QMS, ensuring proper collaboration and approval, as well as releasing documents▪ Utilized Good Documentation Practices to ensure compliance with regulatory agencies on documents▪ Maintained document filing room

Nj

Harrisonburg, Va

Assisted in reestablishment of first student branch of association to create an entity for biotechnology students to discuss and develop as scientists. Documented and organized monthly meetings to maintain a proper record for future leaders. Designed and monitored outreach tools and social media including core representation of the association to gain further membership

Harrisonburg, Va

Examined gene expression in Bordetella avium, a bacteria that causes an upper respiratory infection in turkeys somewhat similar to that of B. pertussis in humans.-Examined the regulation of genes coding for two Large Secreted Proteins and an upstream Type I Secretion System, which very likely form an operon in the B. avium genome-Compared the prevalence of RNA produced under conditions which simulated when virulence factors were turned on or off.