- 189876 - Document Control Analyst/ Labeling Specialist
- CA-Southern California - San Diego
- Up to $29.25 DOE
- 9 mos
- Chipton-Ross is seeking a Document Control Analyst/ Labeling Specialist for an opening in Carslbad, CA.
The role is responsible for Document Control Management of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG).
BID is experiencing an outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.
We are looking for a self-driven, experienced and resourceful Document Control Specialist to support with the buildout of our document control system, ensuring compliance to all applicable standards.
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.
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.
Accredited Associate’s degree from accredited college/university or equivalent experience.
Accredited Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering preferred.
5 days/week. Monday – Friday. Standard work hours
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x260 or (800) 927-9318 x260
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.