Experience Inc. Jobs

Job Information

Actalent Document Control Specialist in Newark, California

Description:

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 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.

Skills:

scanning, gmp, data entry, document control, Quality Systems, Adobe, Electronic document management system (EDMS)

Additional Skills & Qualifications:

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.

Preferred Education:

• AA/AS required, BS prefrerred

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

DirectEmployers