Quality Associate

Pyramid Consulting, Inc

Village of Medina (NY)

Hybrid

USD 33,062 - 34,440

Full time

14 days+

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Health insurance (medical, dental, vision)

401(k) plan

Paid sick leave

Job summary

A leading consulting firm in Medina, NY is looking for a Quality Associate for a 12+ month contract. The role involves managing customer complaints and ensuring compliance with FDA regulations. Candidates should have 2-5 years of experience in a cGMP environment and strong writing skills. This position offers a pay range of $24-$25 per hour along with benefits including health insurance and a 401(k) plan.

Qualifications

Ability to triage incoming complaints and determine next steps.
Respond to customer complaints in written or verbal form.
Participate in CAPA and product improvement activities.

Responsibilities

Manage workflow and escalate issues as needed.
Collect necessary complaint information for investigations.
Write technical investigation response letters.

Skills

Strong knowledge of FDA Quality System

Technical writing skills

Excellent communication skills

Problem-solving and analytical skills

Ability to prioritize risk projects

Education

2-5 years relevant work experience in cGMP related industry

Tools

Computer systems for word processing and reporting

Job description

5 days ago Be among the first 25 applicants

Pyramid Consulting, Inc provided pay range

This range is provided by Pyramid Consulting, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$24.00/hr - $25.00/hr

Immediate need for a talented Quality Associate. This is a 12+ months contract opportunity with long-term potential and is located in Medina, NY or Round Lake, IL (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-82377

Pay Range: $24 - $25/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
Collect necessary complaint information for investigations.
Determine reportability of a complaint.
Respond to customer complaints (written or verbal) and write technical investigation response letters.
Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams). May lead projects as assigned by management.
May have technical approver responsibilities.
Manage workflow; identify and escalate issues. Participate in mentoring and training of the Product Surveillance team. Ability to perform all duties required of previous levels.

Key Requirements and Technology Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
Understanding of the products intended use and manufacturing process of assigned products.
Strong technical writing skills, able to review complaint investigations and write customer response letters.
Readily accepting of assignments to new/ different products.
Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
Excellent written/verbal communication and organizational skills.
Ability to make independent decisions with minimum oversight. Strong problem solving and analytical skills.
Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.
Include the education and experience that is necessary to perform the job satisfactorily.
2-5 years relevant work experience in cGMP related industry or in a clinical setting.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Seniority level