Job title: Quality Systems Document Control Associate
Duration: 12 Months
Location: Northbrook, IL 60062 (Remote)
Schedule: 1st Shift
Responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Medical and Development QMS. Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
· Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality
· Documents for compliance to established standards.
· Ensure all Quality Documents meet required standards before processing documents in the Document Management System - Quality Document (ADMS QD) workflows.
· Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.
· Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Document Management System - Quality Document (ADMS QD).
· Support the development, review and delivery of training materials to provide to new users of the ADMS
· QD system.
· Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards.
· Support Document Control initiatives that lead to process improvements.
· Respond to email inquiries and user support questions.
· Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.
· Functions as the CRQA point of contact for all functional areas utilizing the M&D Quality Management System.
· Supports the CRQA staff of approximately 70 individuals, by offering consultation, advice, and subject matter expertise regarding QMS document control requirements. Processes and manages approximately 125 quality documents per month.
· Reports to the Associate Director, Quality Systems Document Control & Administration.
· No people management responsibilities
· Collaborates directly with CRQA Leadership Team, CRQA staff, and various levels within Medical and Development (M&D) functions including functions outside of M&D that utilize ADMS QD.
· Bachelor of Arts/ Bachelor of Science degree BS/BA.
· 2 - 5 years working experience in the pharmaceutical industry, one of which should be within Quality
· Assurance and/or within SOP writing, Process Improvement or similar discipline.
· Proficiency in Microsoft Office.
· Skills and Competencies:
· Strong interpersonal skills and multi-cultural /intercultural awareness, able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.
· Excellent oral and written communication.
· Ability to work independently, multitask and shift workload according to department/team priorities.
· Strong planning and organizational skills and experience managing multiple priorities simultaneously.
· Working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
· High attention to detail.
· Experience processing documents for review and approval using an electronic system.
Note: This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.
Pay range: $33-$37/hr. on w2 based on experience and skills
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [Click Here to Email Your Resumé] if you require a reasonable accommodation.
For the full list of our open positions, please check www.spectraforce.com