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Document Control Specialist I
7555 Gateway Boulevard Newark, CA 94560 US
Job Description
Position Summary:
Responsible for scanning records and verifying accuracy and completeness of scans. Issue QC data packets for test. Archives records and prepares records for offsite storage. Processes document workflows, reviewing documents for correct format and compliance with company templates.
Essential Functions:
• Scans records and verifies accuracy and completeness of scans.
• Prepares records for offsite storage, creating accurate document indexes and ensuring record integrity is maintained.
• Ensures the correct and timely implementation of document requests in editing of controlled documentation. Verifies own work.
• Performs general word processing support and assists Revance personnel in resolving document format issues.
• Processes document workflows to ensure priority documents are promptly processed to meet timelines.
• Maintains, verifies, and ensures correct and complete database and logbook entries.
• Assists with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems processes.
• Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
• Maintains and performs audit of control binders to ensure that adequate and accurate distribution has occurred. Implements corrective actions if discrepancies are found.
• Applies company policies and procedures to resolve a variety of routine issues. Exercises judgment within defined procedures and practices to determine appropriate action.
• Keeps abreast of the basic requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
• Follows Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.
• Performs other related duties and assignments as required and defined by management.
Physical Requirements:
•Document storage and retrieval may require lifting boxes of documents, carrying documents from one place to another and storing boxes on shelves or in file cabinets.
•Handling documents requires repetitive motion using a variety of scanning and computer equipment.
•Should have good keyboarding skills and manual dexterity.
Skills:
Preferred Experience:
• Two years of document control experience in the pharmaceutical/biotech industry.
• Works under general supervision; showing a general level of independence.
Preferred Additional Skills:
• General knowledge of understanding of Document Control standards, practices, and principles.
• General knowledge of understanding of Quality Systems and applicable GMP regulations and standards.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Effective written and oral communication skills.
• Effective time management and interpersonal skills.
• Possesses initiative and is proactive.
• Experience with databases and is proficient with the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
• Excellent organizational and planning skills.
• Must work effectively within teams with rapidly changing priorities.
• Builds productive internal and external working relationships.
• Demonstrates good coping skills and analytical problem solving skills.
Education:
• Required: Completed High School (Diploma or GED)
Preferred Education:
• Typically an AA/AS or equivalent combination of related education and experience.
Pay Rate Range: $20-26/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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