Quality Compliance Contractor

US-IL-Chicago
3 weeks ago
ID
2017-1994
Adello Biologics, LLC

Overview

Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

 

Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Quality Compliance Contractor to be based out of our Chicago, IL location. 

Responsibilities

SUMMARY:

This role is a contract position at Adello Biologics, LLC, in Chicago, IL reporting to the QA Manager.

As an integral quality team member, individual provides assurance that all products and quality system processes in the facility are in compliance with CGMP requirements and company policies and procedures. This function will lead Adello’s Supplier Quality Program, conduct external and internal audits per the audit schedule to assess the state of compliance, update Quality system procedures and support QC lab function as needed. This function will need to interact with all departments within Adello and with suppliers globally as well as within the US. The individual should be able to manage a broad spectrum of projects to support the needs of Quality Management and act as a backup to the QA Manager when needed. This function will assist with facility inspection readiness activities and previous experience with FDA inspections is preferred. Should be able to travel for external audits (approximately 20% of work time).

 

 

Essential Duties and Responsibilities:

  • Oversees the development and implementation of quality assurance procedures governing the facility quality systems and ensures compliance with cGMP regulations, customer expectations and company policies.
  • Oversees the Supplier quality function and ensures procedures and systems are in place to evaluate, control and monitor incoming product quality. Ensures suppliers are thoroughly evaluated, scrutinized and approved per procedures to ensure incoming material meet Adello standards and cGMP.
  • Oversees the External Audit program and leads supplier audits globally as well as within the US. Maintains strong supplier relations and interfaces with suppliers to resolve any quality findings, supplier complaints etc.
  • Performs quality assurance walk-through audits and/or internal audits of manufacturing, laboratory and warehouse areas to ensure compliance with cGMPs and company procedures.
  • Prepares audit agenda, audit checklists, audit reports and approves audit responses.
  • Monitors supplier change notifications and supplier complaints. Collaborates with functional leads to assess quality impact on product and necessary corrective actions.
  • Leads internal investigations, performs root cause analysis using appropriate tools and implements necessary CAPAs.
  • Performs gap assessments, quality risk assessments and leads quality improvement efforts.
  • Monitors effectiveness of Quality systems, generates quality system event metrics and trend analysis for management review, escalates issues and drives resolution.
  • Assists with quality improvement efforts in the QC lab, which may include but not limited to revising QC procedures, improving processes to drive efficiency, assisting with lab investigations, enhancing the stability program, training lab personnel.
  • Stays current on Compliance matters, recent 483’s / warning letters, regulations and industry trends.
  • Has familiarity with 21 CFR PART 210, 211, 11 and 820, USP requirements, FDA and ICH guidance.

Qualifications

PREREQUISITES:

Education / Experience:

  • BS degree in life sciences (Biology, Chemistry, etc.) with 7-10 years’ relevant industry (Biotech/Pharma) experience.
  • MS degree in life sciences (Biology, Chemistry, etc.) with at least 5 years’ relevant industry (Biotech/Pharma) experience.
  • Knowledge of GMPs and their application in the commercial environment is required.

Certification:

  • ASQ certified quality auditor (CQA) preferred

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Strong and clear communication skills, both written and verbal.
  • Should possess strong technical writing skills, analytical thinking and problem solving skills.
  • Presentation of data and reports to small/large groups is part of the job.
  • Requires the ability to influence and change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship.
  • Exercises due professional care and works with a high level of integrity.
  • Positive can-do attitude, flexible, resourceful and a team player.
  • Excellent computer skills in Microsoft Office applications.

 

 

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

  • Typing, desk work and plant auditing 8-10 hours/day.
  • Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
  • Safety alertness is required due to work around hazardous equipment and conditions.
  • Travel required for supplier audits, approx. 20% of work time.

 

 

Noise:

  • Noise levels commensurate with shared office space.

 

Standing/Lifting:

  • No extraordinary requirements

 

                      

Visual:

  • No extraordinary requirements.

 

Stress:

  • High-paced demanding environment to meet ambitious project goals.

 

 

Travel:

  • Approximately 20% of work time

 

 Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

 

Notice To Agency And Search Firm Representatives

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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