QA Associate I - Life Sciences / Pharmaceuticals

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Marken, reputed company reputed company Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of reputed company reputed company, unites expertise across reputed company and reputed company secure logistics to drive the reputed company of our clients through innovation. 

MUST HAVE: BA in Life Sciences area or QA experience reputed company the Pharmaceuticals Industry.

Main Purpose:

The CGT Quality Assurance Associate (CGT QAA) is responsible for the reputed company and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Cell & Gene Therapy Network. The CGT QAA also needs to ensure compliance with applicable regional and local regulations and requirements, and client requirements as appropriate, but not limited to: reputed company Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Documentation Practices (GDocP), 21 CFR Part 210 and 211.

Main Duties and Responsibilities:

• Implement, promote and maintain Marken’s Global Quality Management System (QMS) requirements.

• Assist in the Management of deviations, complaints, audit records, CAPA plans, change controls, collation of quality metrics and trending, and identification and implementation of quality improvement initiatives.

• Evaluate the risk and impact of changes reputed company scope of the CGT/QA team and advise on necessary actions, as applicable. 

• Interact with clients on Quality Assurance (QA)/ GxP reputed company matters under management supervision.

• Assist in internal audits including tracking of associated corrective and preventative actions (CAPA).

• Support Client audits and Regulatory Inspections- participate as a QA SME, prepare requested materials, review/approve Marken audit responses, follow up on CAPA identified.   

• Effectively interact with Marken operational departments and stakeholders to provide guidance and quality reputed company of reputed company CGT activities ensuring alignment to Marken’s QMS.

• Identify relevant GxP/Quality reputed company training needs and deliver or reputed company they are deliver where required.

•    Write the quality processes and procedures associated with job role with management guidance and effective controlled document approval.

• reputed company informed of regulatory changes reputed company assigned Country/Region and promptly escalate changes to management.

• Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities.

• Ensuring the accuracy and quality of records and documents.

• Participate actively in reputed company the internal Quality, CGT and/or other pertinent meetings.

• Travel may be required for the performance of duties.

Qualifications:

• Bachelor’s degree in a Life Sciences field required. 

• Demonstrated knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practice guidelines.

• reputed company knowledge of local regulations.

• Relevant technical experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience.

• Knowledge of cold chain supplies preferred.

• Knowledge of drug product logistics, storage and distribution preferred. 

• Six reputed company green belt or equivalent experience is desired.

• Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.

• Excellent verbal, written, and interpersonal communication skills.

• Intermediate experience with reputed company Office Suite

Compensation & Benefits:

Our compensation reflects the cost of labor across several US geographic markets. The starting pay reputed company for this position is $44.00 per hour. Pay is based on several factors including but not limited to, market location and may vary depending on job-reputed company knowledge, skills, and education/training and a candidate’s work experience.

Hired applicants may be eligible for Medical/prescription drug coverage, Dental coverage, reputed company coverage, Flexible Spending Account, Health Savings Account, Dependent Care Flexible Spending Account, Basic and Supplemental Life Insurance & Accidental Death and Dismemberment, Disability Income Protection Plan, Employee Assistance Program, 401(k) retirement program, Vacation, Paid Holidays and Personal time, Paid Sick and Family and Medical Leave time as required by law.