Job description

Job Responsibilities:

• We are looking for someone to support our QA team by completing activities in the following areas as assigned by the QA/Compliance Manager or QA Site Leader:
• Support activities and improvement in key QMS areas including, but not limited to CAPA, Training, Quality Records Management, Internal Auditing, Change and Document Control, Quality Metrics
• Procedural development/improvement
• Data Collection and report generation Development/Execution of Quality Plans External Audit support Monitoring and reporting of metrics Daily operations activities for Site QA as assigned
• Document Control and Records Control, CAPA, Training, Complaint Handling, Internal Auditing)

Qualifications:

• Bachelor's degree (Preferred) and 1-2 years' experience in QA/Compliance within the Life Sciences Industry
• Working knowledge of Pharmaceutical or medical device regulations (including FDA QSRs, ISO
• Demonstrated ability to work cross-functionally in a team environment
• Ability to work independently with little supervision
• Proficient with the MS Office Suite
• Must be able to observe company policies and safety procedures at all times

Job Type: Full-time

Pay: $67,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• Overtime
• Weekend availability

Work setting:

• In-person
• Manufacturing facility
• Office

Ability to commute/relocate:

• Lexington, MA: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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