Lab Analyst I (2nd Shift)

At Elan, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.Elan's commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement. The Lab Analyst I position is an entry level analyst position. The Lab Analyst I performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner following written procedures and good documentation practices. The Lab Analyst I is required to complete the most comprehensive in-house training program for all laboratory activities. Documented proficiency is required before the Lab Analyst I can perform tasks independently. Because of the level of experience required for this position, the scope of work is generally limited to routine testing explicitly following written test protocols, however, upon the discretion of QC supervisory staff the Lab Analyst I may be called upon to execute non-routine testing to support method validation, and method transfer. In addition, the Lab Analyst I may be called upon to write or revise SOPs, analytical procedures, and analysis reports, or qualify as trainers on specific procedures.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Primary Responsibilities:'Perform testing in accordance with written procedures for: stability samples, raw materials and packaging components, in-process manufactured material, and finished product (bulk or packaged).'Perform testing to support method validations and method transfers.'Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.'Processing of electronic data using procedures that ensure data integrity and security.'Ship samples to contract testing facilities.'Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.'Transcribe results onto analysis reports.'Disposal of laboratory waste on an as needed basis.'Perform and document daily standardization and performance verifications on laboratory equipment.'Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.'Write, revise or review SOP's, analytical protocols, and analysis reports.'At the discretion of QC management, may qualify as trainers on specific laboratory procedures.'Comply with DEA regulations and internal controlled substances security and reconciliation procedures.'Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing.'Identify deviations to written procedures. Write deviation investigation reports.'Identify and report unsafe conditions within the laboratory and sampling areas.Secondary Responsibilities:'Perform attribute testing on capsules and components.'Sample raw materials, packaging components, printed material, retentions samples and bulk products.'Apply approved stickers to packaging components.'Subdivide and label in-house reference standards.'Order reagents and lab supplies that comply with test protocol requirements.'Laboratory reagents and supplies management.'Execute and document preventative maintenance and calibration procedures on laboratory equipment.'Sample log-in verification.'Glassware cleaning and general housekeeping.'Data Security. EDUCATION/EXPERIENCE:Minimum of two year technical degree with one year experience in a pharmaceutical/biologics laboratory environment with cGMP experience required. Four year science background degree (BA/BS) with minimum laboratory experience preferably in the pharmaceutical/biologics industry preferred.COMPUTER SKILLS:To perform this job successfully, an individual should have a good working knowledge of MS Office (Word, Excel, PowerPoint, Access, Outlook). Experience with chromatography data management (CDS) preferred. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2186398&boardid=749&Template=ResponseForm.html