QA Specialist - Worcester, United States - Spectraforce Technologies

Description

:

Job Title:

QA Specialist


Duration:
06 Months (potential extension)

Location:

Worcester, Massachusetts, 1604
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

* Years of experience/education and/or certifications required:

o Bachelor's Degree/ 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?
o Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.

o some form of review experience:

data or record review

o 1+ years within a manufacturing facility


* What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
o some work with investigations

o experience with document revisions

o review of GMP commercial batch records


Interview Process:

o First Round:
30 MS Teams Video interview with Sponsor

o Second Round:
30 MS Teams Video with leadership