Quality Assurance (QA) Compliance Specialist

Description

Quality Assurance (QA) Compliance Specialist II

Location: Lake County, IL - ONSITE

Contract: 1 year with possible extension

Work hours/days:

8:00 AM start, M-F, 40 hours per week, no overtime.

Top skills/requirements for the candidate:

• Skill 1: Excellent keyboarding for document/data change-control management using electronic systems
• Skill 2: Proficient with use of standard office computer applications, emphasis with data export tools and pivot tables
• Skill 3: Proactive, communication and collaboration with Supervisor and Team members. Asks questions as necessary and escalates concerns to Supervisor.
• Skill 4: Efficient work planning, self-checking, execution, and accountability without  requiring excessive direction
• Skill 5: Detailed in assessment, execution, verification, and administration of electronic document change control; does not include scientific content review

Required years of experience, education, and/or certification:

• Associate’s degree. HS graduate with equivalent certification(s) may be considered in lieu of degree
• Scientific document management experience using an electronic document management system

Preferred (but not required) regarding skills, requirements, experience, education, or certification:

• Highly preferred: Direct experience Document Management System e.g., Viva Vault (OneVault), Advanced Excel Skills, Outlook, TEAMS, SharePoint.
• Preferred: Scientific Degree or familiarity with general scientific terminology for pharma use,

Work environment (i.e., group setting vs individual role):

• The candidate will be an individual contributor within an R&D Scientific Compliance group that supports a broad variety of topics and processes in a comfortable, collaborative onsite office setting.

Other notable details about the environment from the hiring manager about this role

• Candidate will be directly responsible to the Document Strategy and Training Team Lead for their document management ‘processes and systems’ training and guidance/assignments with increasing individual worktime as performance merits

What positions/background experience do you feel are successful in this role

• Candidates shall have good business communication skills, a solid knowledge of Microsoft office applications, emphasis with Excel tools, and prior experience document change control management. 

Purpose

• Coordinate and execute document change-control processing activities working directly with the Document Strategy Team (DST) Lead in R&D Global Scientific Compliance; and collaborate with the Learning Management Team, Quality Assurance Documentation Center, and scientific-community business units.

Education and Training

• The position requires a bachelor’s degree or equivalent certification(s), with relevant technical business-oriented document management using an advanced electronic document management system (DMS).
• Company-specific documentation processing and systems training, and assignments' guidance will be provided by the DST Lead. Individual responsibilities will increase as confidence grows.
• Testing is not a required prerequisite for this position.
• Candidate’s company-specific training is typically read-and-understand for applicable processes and procedures to enable support of various scientific document management responsibilities and assignments.

General Requirements and Skills

• Excellent keyboarding for document/data change-control management using electronic systems
• Agile use of standard office computer applications and multi-communication modes, e.g., Microsoft 365 applications, SharePoint
• Proactive, transparent communication and collaboration with DST team leadership and other teams’ members in a fast-paced team-oriented environment
• Readily self-coordinates and organizes inputs from multiple communication pathways. Raises key questions when necessary
• Efficient work planning, self-checking, execution, and accountability without requiring excessive direction
• Detailed in assessment, execution, verification, and administration of electronic ‘process and procedure’ technical document change control; does not include scientific content review
• Highly preferred: Direct experience with an advanced DMS or document management platform, e.g., Viva Vault (OneVault), Microsoft 365, SharePoint
• Preferred: Familiarity with general scientific terminology, e.g., chemist, biologist, instrument, analytical testing, study, clinical, active ingredient, drug product

Logistics

• The candidate will work within a Document Strategy Team (DST), embedded within the Global Scientific Compliance group, within the larger Development Sciences R&D area. The work environment is a modern, comfortable, collaborative onsite work-setting.