QA Specialist in Worcester, MA

Manager's Update:This

is a 100% onsite role

• Must have exp. with batch record review
• Must have quality reviewing experience
• Must have prior quality assurance/Quality Control experience
• Must have some manufacturing exp.
• Must have GXP experience
• Must have good documentation experience
• There is no remote option for this role
• Must have skills: Some GXP experience within the Quality Assurance/Quality Control or manufacturing background
• SAP and TrackWise exp. would be preferred
• Must have an exp. with MS Excel
• Ideally Bachelor’s degree would be preferred
• Associate degree or High School diploma with 3+ years of exp. would work for this role
• Master’s degree would be overqualified for this role
• Bachelor’s degree with some internship exp. within the GXP environment would also work for this role
• There is no lifting required for this role

Work Schedule: Monday to Friday  9-5 or 10-6 is  ideal

Description Details: 

• The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.
• Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. 

Responsibilities : 

• Responsible for various aspects of quality assurance and quality control related to their functional area.
• Ensures that product within the plant is consistently manufactured in conformance with  company Quality System requirements and all applicable regulatory requirements.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs. 

Qualifications :

• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication skills, both oral and written 

Are you open to look at candidates willing to relocate? n/a

Years of experience/education and/or certifications required:

• Bachelor’s Degree OR 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry 

What are the top 3-5 skills requirements should this person have?

• Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.
• some form of review experience: data or record review 

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Bonus: some work with investigations 

What type of environment is this person working in?

?Group setting

?Individual Setting

?Combination of both 

Does this position offer the ability to work remotely on a regular basis or is it an on-site role?  no

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
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