*** NEW REQUIREMENT *** DATA COORDINATOR WITH PHARMACEUTICAL EXPERIENCE REQUIREMENT #13-00820 RECRUITER: ANITA JORDAN JOB LOCATION: CORONA, CA SEPTEMBER 9, 2013 *** CANDIDATE MUST WORK ON OUR W-2 ONLY *** Project Description: Under close supervision, support Manufacturing Operations by performing a variety of clerical and administrative duties required to format, review, maintain and distribute Standard Operating Procedures (SOPs), Batch Records and other types of technical documentation that are required in the execution of pharmaceutical manufacturing and packaging functions. Perform related duties as assigned. Responsibilities: • Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws • Initiate change control process for new and revised manufacturing and packaging documentation including SOPs, Batch Records, forms, and other related documents per established procedures • Update and perform document corrections as warranted • Format documents per redline copy • Proof read documents for grammar, punctuation, and format consistency • Route change control package for assessment and approvals • Coordinate and track issuance of new and revised procedures to support Current Good Manufacturing Practices (cGMP) training requirements • Participate in a full-range of clerical and administrative services • Proficient in operating standard office equipment and personal computer systems • Organize and prioritize work • Detail oriented in reviewing critical documents with accuracy and consistency • Communicate clearly and concisely, both orally and in writing • Establish and maintain cooperative working relationships with individuals contacted in the course of work • Ability to speak, read, write, and understand documentation in English • Respond to common inquiries and problems • Work independently as well as in a team environment • Interface effectively and professionally with all levels of personnel • Handle multiple duties and tasks • Type 45 WPM with accuracy • Intermediate to advanced user of Microsoft Office and database software Requirements: • High school diploma or equivalent GED and a minimum of 2+ years of related clerical work experience • Intermediate user of Microsoft Office and database software is required; advanced user of Microsoft Office is highly preferred • Proficiency in departmental utilized software applications including Trackwise, JD Edwards, and LIMS is a plus • Knowledge of: o cGMP, Food and Drug Administration, DEA, and other regulatory requirements o General understanding of manufacturing processes and equipment procedures o Reading and gathering data for presentation o Effective oral and written communication skills o Business English usage, spelling, grammar and punctuation o Principals of basic mathematical computations o Standard office equipment and personal computer systems o Software applications including Microsoft Office (Word, Excel, PowerPoint, and Access) and database software Required Skills: High school diploma or equivalent GED and a minimum of 2+ years of related clerical work experience This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Anita: anitaj@alphaconsulting
Posted on: Mon, 09 Sep 2013 15:05:54 +0000
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