Quality Specialist (cGMP Pharmaceutical) Job at Masis Professional Group, Bethlehem, PA

eDBiRG5MTEJNeG4xazh0Vzd0YTRtN2o5d3c9PQ==
  • Masis Professional Group
  • Bethlehem, PA

Job Description

Quality Specialist * No C2C or sponsorship available for this job.

$65-75k

Potential Contract-to-Direct for the right person!

Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist. In this position, you’ll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide!

Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.

Essential Duties & Responsibilities

  • Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products.
  • Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control.
  • Manage multiple priorities while providing leadership, guidance, and feedback to team members.
  • Drive packaging OEE (Overall Equipment Effectiveness) initiatives.
  • Support qualifications, deviations, customer complaints , investigations, and systems compliance.
  • Maintain oversight of the PAS-X system and ensure 24/7 audit readiness.
  • Support regulatory audits with thorough preparation and follow-through.
  • Lead document control activities to ensure accuracy, consistency, and compliance.

Education & Experience

  • Bachelor’s degree or higher in a scientific, quality assurance, or technical field.
  • 1+ years of experience in the pharmaceutical or related regulated industry .
  • Knowledge/understanding of cGMPs, regulatory standards, and industry best practices.
  • Ability to assist in investigations, interpret regulations, and make sound quality decisions.
  • Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels.
  • Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
  • Strong problem-solving skills with the ability to lead projects and deliver timely results.

Job Tags

Long term contract, Contract work, Worldwide,

Similar Jobs

Risus Talent Partners

Senior IT Compliance Analyst Job at Risus Talent Partners

 ...Overview The Senior IT Compliance Analyst supports the companys security and compliance initiatives, with a primary focus on the SOX ITGC framework. This role is responsible for developing and implementing internal controls, facilitating audits, and ensuring ongoing... 

Renewable Concepts

Major Components Wind Technician Job at Renewable Concepts

 ...We are searching for skilled and experienced Major Components Technician with solid experience working with on wind turbines and who can conduct heavy rigging operations to facilitate replacement components. This role requires in-depth knowledge and hands-on experience... 

Berkot's Super Foods

Loss Prevention Supervisor Job at Berkot's Super Foods

 ...theft or suspicious behavior. Conduct internal and external investigations in accordance with company policy and local laws. Perform...  .... Qualifications Associates or bachelors degree in Criminal Justice, Business, or related field strongly preferred .... 

Locke Staffing Group

Senior Project Manager Job at Locke Staffing Group

 ...a nationally respected GC. If youre a seasoned project leader ready to take on major Bay Area public work, wed welcome a confidential conversation. Interviews are scheduled to take place next week so if youre interested in hearing more about this and other... 

John J. Campbell Co., Inc.

Roofing Service Technician Job at John J. Campbell Co., Inc.

Company Description John J. Campbell Co., Inc. is a recognized leader in the commercial roofing and sheet metal industry. With offices in Memphis, TN, and Birmingham, AL, the company provides comprehensive services including new construction, renovation, repairs, preventative...