Quality Assurance Specialist

Aequor; Summit (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a QA Label Specialist to support their Quality Assurance Label Control operations. In this role, you will be responsible for managing the issuance and reconciliation of production labels, ensuring compliance with health authority requirements, and collaborating with cross-functional teams. The ideal candidate will possess strong project management skills, a keen attention to detail, and the ability to thrive in a fast-paced environment. If you are passionate about quality assurance and looking to make a significant impact in the pharmaceutical manufacturing sector, this opportunity is perfect for you.

Qualifications

• Bachelor's degree with 2+ years of experience in a cGMP/FDA regulated environment.
• Minimum of 1 year of relevant labeling experience required.

Responsibilities

• Support activities for the Quality Assurance Label Control group.
• Issue clinical and commercial in-process and final product labels.

Skills

Label issuance

Project Management

SOP writing

Communication skills

Customer service skills

Analytical mindset

Time management

Problem-solving

Education

Bachelor’s degree

Tools

MS Office

Document Management System

Quality Management System

Adobe

Visio

Excel

Job description

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

Base pay range

$35.71/hr - $35.71/hr

Direct message the job poster from Aequor

Job Title: QA CTO Label Specialist

Location: Summit, NJ – 100% Onsite

Duration: 6 Months Contract

Rate: $35.71/hr on W2 (Without Benefits)

Shift Schedule: Wednesday to Saturday (4:00 PM – 2:00 AM) | 2nd Shift

Must Haves:

• Label issuance, deviations, CAPA, SOP writing, Project Management, Pharma background

Job Description:

The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. To succeed in this role, you will have a strong attention to detail and an analytical mindset.

REQUIRED COMPETENCIES:

Education:

• Required Bachelor’s degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment

Experience Basic Qualifications:

• Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
• Strong communication and customer service skills.
• Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
• Develop and improve label issuance processes to drive operational efficiency.
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
• Ability to work effectively and collaboratively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
• Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network.

DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:

• Supports all activities for the Quality Assurance Label Control group.
• Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
• Coordinates with production teams to ensure timely issuance of labels.
• Performs training of label control and issuance requirements for internal personnel as needed.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.

WORKING CONDITIONS (US Only):

• Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
• Weekend and off-shift support may be required.
• Occasional lifting of heavy weights up to 25 to 35 lbs.

Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing