QA Specialist in Worcester, MA

Shift timings: 9-5 but 10-6 preferred

No OT

100% onsite role

• Batch record review
• Quality Documentation
• GMP
• Associates or Bachelors degree
  

• Verify batch records.
• Science degree needed (Chemistry, biochemistry or any science degree).
• Pharma exp needed.
• Bachelor’s degree needed minimum with 2-3 yrs exp needed.
• Associates degree with 10 yrs. exp will work
• Review batch records.
• Documentation exp needed.
• Sometimes operator may come to their desk to make corrections.
• Strong communication skills
• Documentation review exp is helpful.
• Review GMP documentation.
• Interacting with manufacturing associates
• Review batch records on the floor.
• QA operations exp is better.
• GMP exp is the key.
• this is not electronic batch records.
• On the floor role
• Quality background needed.
• May not be doing correction-based items.
• Quality mindset is the most important requirement.
• High School will not work for this role.
• Quality experience needed.
• Masters degree will be overqualified but willing to consider if the candidate is interested in this role.
• EDMS exp is a must have for this role.
• Veeva is the system client uses.

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/ 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
• 1+ years within a manufacturing facility

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

• Bonus: some work with investigations
• Bonus: experience with document revisions
• Bonus: review of GMP commercial batch records

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

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