Talent.com
Quality and Regulatory Services Associate
Quality and Regulatory Services AssociateTalentBurst, Inc. • Tewksbury, MA, US
Quality and Regulatory Services Associate

Quality and Regulatory Services Associate

TalentBurst, Inc. • Tewksbury, MA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [job_card.permanent]
[job_card.job_description]

Job Description

Job Description

Job Title : Quality and Regulatory Services Associate

Location : Tewksbury, MA (Hybrid)

Duration : 06+ Months

Schedule : Full-time, 40 hours expected. M-F, 8am - 5pm OR 10am - 7pm

Job Description :

Possibility for hybrid (3 days per week in office) for exceptional candidate once training period is complete. No relocation expenses will be reimbursed.

Interview Process : First-Round 30 min Video Interview, Second-Round Onsite Panel Interview

Purpose of Position (i.e. projects involved with and role within group) :

" Responsible for providing front line support for internal and external customers regarding quality and regulatory related inquiries and issues, and act as liaison between customers and other Client departments and functions.

" Responsible for supporting the projects and ongoing processes associated with Quality and Regulatory Services (QRS)

Day to Day Responsibilities :

Ongoing Tasks

" First level triage of customer complaints and QRS email queue. Sort incoming emails quickly, identify duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines

" Escalate key customer and urgent inquiries to the correct department as needed on demand according to QRS guidelines

" Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction

Project Tasks

" Work with cross functional teams including Scientific Support, Marketing / Communications, Business Operations, Sales, Quality and Regulatory, Customer Service on continuous improvement projects to delight our customers

Key Decision Areas

" Daily priorities as well as timely positive professional communications to external customers, business colleagues and teams

Criteria for Performance Evaluation

" Work targets and schedules are met

" QRS guidelines and policies are followed, including use of email templates for customer communication

" Effectively, positively & professionally interact with internal and external customers

" Demonstrates cooperative daily positive interactions with Customer Service, Quality and Regulatory, Supply Chain, Scientific Support, Sales and Business Operations teams regarding distributors and customers' needs / requests

" Able to appropriately determine which inquiries and issues should be escalated, and follow escalation paths as defined by QRS procedures

Required Skills (These are skills that candidates MUST possess)

" Demonstrated capacity for handling time sensitive varying customer requests and prioritizing / escalating tasks accordingly

" Skilled in all Microsoft Office applications. Ability to quickly learn and adapt to new systems.

" Customer facing, manufacturing and / or Quality / Regulatory experience in medical device and / or clinical industries

" Courteous, articulate and professional oral and written communication skills

Desired Skills (These are skills that would be nice for candidates to possess)

" Experience designing and maintaining reports and metrics

" Knowledgeable in use of ETQ, Sharepoint, salesforce.com and PeopleSoft.

" Passion for innovation, automation, and continuous improvements

" Multi-lingual skills highly desired

Education and Experience (minimum required for consideration)

" HS Diploma / GED or Associate's Degree minimum required

" At least 2-4 years of work experience in a customer facing role

" Demonstrated knowledge of quality and regulatory practices strongly encouraged

Soft Skills (Communication / Team / Leadership)

" Ability to work under pressure while maintaining professional and positive composure

" Ability to apply good judgment and business acumen

" Desire to anticipate, meet and exceed the expectations and needs of our customers

" Positive attitude and outlook

" Proven track record of positive customer interaction and teamwork

" Ability to handle proprietary and delicate situations appropriately, positively and professionally

" Capability to effectively and professionally communicate with customers and colleagues from various regions and industries

#TB_EN

#ZR

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

[job_alerts.create_a_job]

Regulatory Associate • Tewksbury, MA, US

[internal_linking.similar_jobs]
Quality Systems Specialist

Quality Systems Specialist

DEKA Research and Development • Manchester, NH, United States
[job_card.full_time]
As a Quality Systems Specialist, you will contribute in the following areas : .Conduct Receipt and processing of field returned product. Review and approve quality records to ensure accuracy, complete...[show_more]
[last_updated.last_updated_30] • [promoted]
Cannabis Sales Associate

Cannabis Sales Associate

Green Thumb Industries • Dracut, MA, United States
[job_card.full_time]
RISE Cannabis Sales Associate engage in one-on-one interaction with patients from the time they enter the retail area until they check out and exit the store. Our ideal Cannabis Sales Associate cand...[show_more]
[last_updated.last_updated_30] • [promoted]
Quality Inspector

Quality Inspector

restor3d • Wilmington, MA, US
[job_card.full_time]
The Quality Inspector will be responsible for quality inspection / quality assurance activities.This includes interpretation and implementation of quality standards to routine inspection / testing and ...[show_more]
[last_updated.last_updated_1_day] • [promoted]
Quality Engineer III (NH)

Quality Engineer III (NH)

GCR Professional Services • Hudson, NH, US
[job_card.full_time]
Quality Engineer III (Location : Nashua, NH area) Qualifications •The manager is looking for a Quality Engineer who can focus on the end products specifications and quality standards.Familiarity wit...[show_more]
[last_updated.last_updated_30] • [promoted]
Associate Director, Drug Safety Operations - Systems

Associate Director, Drug Safety Operations - Systems

Talent Groups • Waltham, MA, US
[job_card.full_time]
We are seeking an Associate Director, PV Systems to manage and enhance its global Argus Safety platform and PV reporting systems. This role will lead end-to-end safety systems activities including c...[show_more]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Fulfillment Associate (DRACUT)

Fulfillment Associate (DRACUT)

Lazy River Products • Dracut, MA, US
[job_card.part_time]
Fulfillment "Fill" Associate.The Fulfillment Associate is responsible for fulfilling customer orders, ensuring every order is compliant with state regulations. Fulfillment Associates work ...[show_more]
[last_updated.last_updated_30] • [promoted]
Sr Director Rebate Invoice and Audit - Synergie Medication Collective

Sr Director Rebate Invoice and Audit - Synergie Medication Collective

Blue Cross Blue Shield Association • Manchester, NH, United States
[job_card.full_time]
The hiring range for this role is : .This is the lowest to highest salary we.A candidate's position within the.Note : No amount of pay is considered to be wages or compensation until such amount is ea...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Remote Text Quality Evaluator

Remote Text Quality Evaluator

Outlier • Manchester, NH, United States
[filters.remote]
[job_card.full_time]
Additional pay available based on project performance.Freelance / 1099 contract — not an internship.Flexible hours — you choose when and how much to work. Weekly via our secure platform.Outlier, a pla...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Sr. Quality Control Analyst

Sr. Quality Control Analyst

Pace Analytical Services, LLC • Waltham, MA, United States
[job_card.full_time]
Monday through Friday, 8 : 00 AM - 4 : 30 PM.Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward. to innovate and advance all aspects ...[show_more]
[last_updated.last_updated_30] • [promoted]
Quality Training & Records Coordinator

Quality Training & Records Coordinator

Merrimack Manufacturing • Manchester, NH, US
[job_card.full_time]
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard.We are a growing manufacturing company that will play a crucial part in bringing innovative and...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Quality Inspector

Quality Inspector

Trexon • Hudson, NH, US
[job_card.full_time]
The Quality Inspector plays a critical role in ensuring that all products meet the company's high standards for quality and precision. This position involves inspecting components and finished p...[show_more]
[last_updated.last_updated_30] • [promoted]
Staff Applied Scientist

Staff Applied Scientist

Relativity • Manchester, NH, United States
[job_card.full_time]
At Relativity, we're building a world-class Applied Science team to push the boundaries of intelligent systems in the legal domain. We're looking for a Staff Applied Scientist to join our team.Agent...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Inspection Associate

Inspection Associate

HW Staffing Solutions - Nashua NH • Londonderry, NH, US
[job_card.full_time]
Job Title : Inspection Associate.Pay Rate : $27–$28 per hour.Work Environment : Bench area within the Receiving room.We’re looking for a skilled Inspection Associate to join our quality te...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Quality Inspector III

Quality Inspector III

Amphenol Printed Circuits • Nashua, NH, US
[job_card.full_time]
This position is responsible for inspection of Printed Circuit Boards in the final stages.This position will also be able to create final packages before bringing job to shipping department.Visual ...[show_more]
[last_updated.last_updated_30] • [promoted]
Senior Manager, Regulatory Affairs (Biosimilars)

Senior Manager, Regulatory Affairs (Biosimilars)

Fresenius Kabi USA, LLC • Manchester, NH, United States
[job_card.full_time]
The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...[show_more]
[last_updated.last_updated_30] • [promoted]
Regulatory Affairs Professional

Regulatory Affairs Professional

804 Technology • Newton, MA, US
[job_card.full_time]
Contract Position As a Regulatory Affairs Specialist Consultant, you will be responsible for : Formulate and execute activities associated with regulatory submissions of a novel robotic medical devi...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Senior Director, Regulatory CMC

Senior Director, Regulatory CMC

Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
[job_card.full_time]
The Senior Director, Regulatory CMC will lead and evolve Apellis's global Chemistry, Manufacturing, and Controls (CMC) strategies to support the company's innovative therapeutic pipeline and market...[show_more]
[last_updated.last_updated_30] • [promoted]
Quality Specialist

Quality Specialist

Paragonix Technologies, Inc • Waltham, MA, US
[job_card.full_time]
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically tru...[show_more]
[last_updated.last_updated_variable_days] • [promoted]