Document Control Specialist
2 weeks ago
Summary
The Document Control Specialist role supporting Document Control and Records Management. They will be responsible for maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas. The individual will be responsible for formatting and administration of paper-based and electronic document workflows as well as chain of custody, issuance, and archival of paper records. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.
Responsibilities
- The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas
- The individual will be responsible for formatting and administration of paper-based and electronic document workflows as well as chain of custody, issuance, and archival of paper records
- Support cross functional teams in processing document requests, document approval, and document archival
- Issuance and reconciliation of paper records (i.e., batch records, logbooks, protocols)
- Manage the archival of all GMP documentation both on-site and off-site (organization and maintenance of the on-site archival room)
- Develop and implement process improvements for Document Control and Records Management processes
- Assist in document control process improvements including document types, lifecycles, and workflows in eDMS
- Revise SOPs related to Document Control, Records Management
- Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents
- Provide document control/records management support for internal/external audits and inspections.
- Other duties as assigned.
Skills and Qualifications
- BS degree with 3-5 years of Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight OR 2 years of experience with MS degree
- Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation
Additional Skills Required:
In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
· Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
· Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
· Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
· Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
· Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
· Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
· Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
· Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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