Mastech Digital is an IT Staffing and Digital Transformation Services company.

QA Manager

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Location: Waltham, MA
Job Code: 219931
Posted: Nov 18, 2020

Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a QA Manager for our client in the Consulting domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Permanent position and the client is looking for someone to start immediately.

Duration: Full-time

Location: Waltham, MA (Onsite Role)

Interview Mode: Telephonic + Onsite interview

Role: QA Manager

Note: As per market rate +benefits (Flexible PTO, Training and, Development Opportunities, 401(k) match, Bonus Eligibility, Medical Benefits, Paid Holidays)

Primary Skills: Quality Assurance

Role Description: The QA Manager must have at least 5+ years of experience. 

Required Work Experience: 

- A minimum of 5-7 years of experience in the biopharma industry with increasing responsibility within Quality Management functions. 

- Previous managerial or supervisory experience. 

- Experience with FDA and other similar regulations related to cGMP manufacturing and quality management. 

- Experience with quality management systems related to cGMP activities in the biopharma industry. 

- Experience with electronic documentation/quality management system in a regulated environment. 

Preferred Experience: 

- CQA/CQE or similar quality certification. 

- Experience performing supplier/vendor audits. 

- Experience with cell and gene therapy related equipment and processes. 

- Experience in early phase manufacturing guidance’s (PDA TR 56) 

- Experience managing Environmental Monitoring programs 

- Experience implementing and managing Raw Material programs 

- Experience implementing and maintaining Operational Excellence programs 

Required Education: 

- Bachelor’s Degree 

Preferred Education: 

- Bachelor’s Degree in a scientific discipline, preferably engineering or life sciences.

Required Knowledge: 

- Microsoft Office 

- Microsoft Visio 

- eQMS, eLMS, eDMS 

Skills (Inc. Typical Mental Demands): 

- Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills: Computer skills, basic engineering and mathematical skills, use of spreadsheets. 

Additional Qualifications: 

- Communication proficiency between clients, direct reports, and peers; both in person and during conference calls 

- Attention to detail 

- Can work productively independently without supervision 

- Self-motivated, flexible, dependable and available 

- Excellent organizational and time management skills 

Education: Bachelor’s degree in Computer Science, Electrical/Electronic Engineering, Information Technology or another related field or Equivalent.

Experience: Minimum 5+ years

Relocation: This position will not cover relocation expenses

Travel: No

Local Preferred: Yes

Recruiter Name: Anil Chamoli

Recruiter Phone: 412-436-0333 (Ext: 2034)

Equal Employment Opportunity

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