Senior Manager QA Media Operations

Organization
HackEd
Job Location
Walkersville, MD 21703
Salary
Competitive
Job Description

We are seeking a Senior Manager QA Media Operations

Primary Responsibilities

  • Directs staff of QA media operations specialists that review and approve device master records, batch records, testing, and aseptic operations. Oversees batch release.  Develops and plans strategy and  departmental goals, establishes timelines and monitors progress and completion.
  • Provides oversight of aseptic operations including managing QA on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex,  Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820). Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
  • Provides direction for complex deviations and complaint investigations; Managing media deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.
  • Leads or supports regulatory or client audits as Aseptic Media subject matter expert.
  • Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensures process is efficient.

 

Safety

  • Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
  • Ensure that all team members comply with safety rules and regulations.

 

Quality Responsibility

  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Requirements

Education

  • Bachelor’s degree in life sciences required. Preferred area of study:  Life Sciences

 

Experience

  • At least 10 years of GMP experience in biologics manufacturing or equivalent including at least 7 years management experience with at least 5 years in a QA supervisory or management role.   Working knowledge of cell culture starting materials and aseptic processing experience required.
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations and medical device regulations.

 

Knowledge

  • GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred. Working Knowledge of endotoxin testing required.

 

Skills

  • Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic. The ability to interface and communicate directly with clients may be required.
  • Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects. text.

 

Qualities & Attitude

  • Strong collaboration and communication skills required. Ability to multitask and adequate sense of urgency a must.
How to Apply

Send resume, name and job title to sherita.smaw@hackeducate.com

 

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