HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement 
with one of our Direct client's (No hidden Layers) , please review below job 
description and let me know your interest


Position ID: DYESJP00018038
Title: BSA- QA with CAPA
Duration: 12 months, with possibility for extension
Location: Lake Country, IL

Locals preferred - 3 days onsite/ 2 days remote highly preferred

Description Details

* Are you open to look at candidates willing to relocate? Can be remote, Lake 
County, IL highly desirable
* Years of experience/education and/or certifications required: 3-5 years, 
bachelor's degree
* What are the top 3-5 skills requirements should this person have?
1: Strong Communication skills
2: Experience leading end-user IT system deployments - converting URS/use case 
into UAT; leading UAT; facilitating business community to create and/or update 
procedures; facilitate creation of and deliver end-user training (self-directed 
and/or ILT); establishing key user groups for hypercare period and transition 
to business as usual. Flexibility, adaptability to dynamic prioritization of 
workload - agility- looking for Agile candidates that are able to pivot 
depending on the need
3: Ability to work with minimal direction knowing when to seek clarity, 
guidance, direction
4: SDLC, in regulated environment (in pharma highly desired)

* What is a nice to have (but not required) regarding skills, requirements, 
experience, education, or certification? Familiarity with Quality processes 
such as functional (internal) audit, supplier qualification and management, 
external manufacturing quality, supplier audit.

* Work Schedule (Define days,# of hours)/ Is Overtime offered or required? 
Mon-Fri 8-5pm
* Does this position offer the ability to work remotely on a regular basis or 
is it an on-site role? On-site preferred, Remote is available

Description:

Responsibilities:
* Will lead and/or facilitate the business activities required for successful 
IT system implementations.
* Ability to deliver results with minimal instruction, direction and leadership 
inputs. Able to work comfortably with risk and ambiguity.
* Can bring previous experience and outside influencers, diverse opinions and 
inputs to enhance outcomes.
* Openly and honestly communicates status, risks, issues of work assignments, 
working toward common goals and desired outputs.
* Ability to lead small projects with limited supervision, including scope, 
schedule, resources and budget, with a focus on quality and compliance.

* Supports project and program management to ensure proper and accurate status 
is communicated to key stakeholders including program and ITand BTS leadership.
* Ensures documentation is current and accurate, fact-based and relevant.
* Responsible for compliance with applicable Corporate and Divisional Policies 
and procedures.

Qualifications:

* College degree in Information Systems, related field, or equivalent work 
experience is required.
* 3-5 years of prior experience in this type of role
* Experience in the development and implementation of large-scale/enterprise IT 
systems.
* Knowledge of Quality system concepts and business processes such as product 
complaint handling, supplier quality management, CAPA, non-conformance, change 
management and internal/external audit.
* Excellent interpersonal skills and well-developed verbal and written 
communication skills.
* Must be able to effectively lead and facilitate meetings (and informal 
discussions) including the preparation of meeting materials and documenting 
meeting minutes, agendas and clear statements of participant expectations.
* Must be work-product focused and detail oriented, have exceptional teamwork 
skills and a strong business stakeholder focus.

Interview Process

* Please define your required Interview Process (Phone or in-person interview) 
**Important to describe that extensive interviews could cause loss of talent 
and a bad candidate experience (see Hiring Manager Interview Guide):
* Is there anything that may prevent you from conducting interviews in a timely 
manner (i.e. vacation, business travel, etc.)?:
* Who will be involved in the interview process? Define contacts: Paul Horvath, 
Jacquelyn Schueler
* Ensure you book an interview feedback call with the manager for as soon as 
the last interview is due to finish



Thanks & Regard's

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 701-5896 /(c) 224-635-0898



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