191901 - Document Control Analyst
Industry
PRO
Region
CA-Southern California - San Diego
City
Carlsbad
State
CA
Rate
Up to $25.00 DOE
Duration
7 months
Description
Chipton-Ross is seeking a Document Control Analyst for an opening in Carlsbad, CA.


RESPONSIBILITIES:
Day-to-day support of the document control workflow, which is the vehicle to execute the request for changes within a ISO 9001 and Pharmaceutical GMP Quality Management System.
Support the coordination, preparation and implementation of controlled documents via Document Change Orders (DCOs) and Engineering Change Requests (ECRs).
Review and edit product documentation for consistency in content. Interact with appropriate departments/sites to resolves discrepancies.
Assist with global document review boards ensuring that document changes which impact multiple sites are appropriately updated congruently to prevent process drift.
Drive continuous improvement of Document Control process by employing Practical Process Improvement concepts, managing metrics, reporting and communicating internally to Leaders and diverse audiences.
Determine required approvers and route corresponding DCO/ECR in Agile. On completion of change, ensure manufacturing documentation is available at the point of use. Provide notification to appropriate departments, where applicable.
Prepare physical binder of Quality Management System (QMS) documents for audit support.
Train staff to document control processes, Good Documentation Practices (GDP), etc.
Compile master data for entry into Agile document management system
Transfer documents to new approved templates
Perform other duties and cross training, as assigned


REQUIREMENTS:
Requires a minimum of 2-3 years relevant experience in a regulated document control environment.
Strong working knowledge of computer applications and current software (Microsoft Excel, Outlook, Word, Project and PLM/ERP system).

Experience with Agile and MasterControl electronic document control systems preferred.
Works independently on new and on-going assignments.
Identifies and solves problems using established business rules and procedures.
Detail oriented and accurate.
Strong verbal and written communication skills.
Continuous improvement minded.
Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001, ISO 13485, MDSAP, excipient manufacturing regulations) and 21 CFR part 210/211, ICH Q7 and Eudralex volume 4 experience preferred.

EDUCATION:
Associate’s degree from accredited college/university or equivalent experience. Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering preferred.

SHIFT:
Full-Time

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Rochelle Anderson
randerson@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x280 or (800) 927-9318 x280

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.