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Job Requirements of Field Specialist QA Operations:
-
Employment Type:
Contractor
-
Location:
Devens, MA (Onsite)
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Field Specialist QA Operations
Careers Integrated Resources Inc
Devens, MA (Onsite)
Contractor
Job Title: Field Specialist QA Operations
Location: Devens, MA 01434
Duration: 3 Months+ (Possible Extension)
Pay rate: $57.84/hr. on W2
Work Schedule:
JOB SUMMARY:
JOB RESPONSIBILITIES:
EDUCATION REQUIREMENTS:
QUALIFICATIONS REQUIRED:
Location: Devens, MA 01434
Duration: 3 Months+ (Possible Extension)
Pay rate: $57.84/hr. on W2
Work Schedule:
- 2-week rotating schedule:
- 5:00 AM – 5:30 PM, 2 on (Tue, Wed)
- 2 off (Thu, Fri)
- 3 on (Sat, Sun, Mon)
- 2 off (Tue, Wed)
- 2 on (Thu, Fri)
- 3 off (Sat, Sun, Mon)
- Holidays included as the needs of the business warrant.
JOB SUMMARY:
- Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the LSCC in Devens, MA.
- The Contractor Field QA Specialist is responsible for quality activities for the LSCC in accordance with Client policies, standards, procedures, and Global cGMP.
JOB RESPONSIBILITIES:
- Perform QA on the floor activities.
- Ensure manufacturing compliance with applicable procedures and batch records.
- Perform real-time review of manufacturing batch records.
- Review manufacturing shop floor documentation.
EDUCATION REQUIREMENTS:
- Relevant college or university Associate's or Bachelor's degree required.
- Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
QUALIFICATIONS REQUIRED:
- Equivalent combination of education and experience might be acceptable.
- Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Understands continuous improvement and improves efficiency and productivity within the group or project.
- Builds relationships internally within and with cross-functional teams.
- Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer knowledge of GMP Manufacturing operations and processes.
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Routinely recognizes and resolves Quality issues; informs management of proposed solutions and seeks guidance on complex issues.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Must possess an independent mindset; work is self-directed.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Confident in making decisions for non-routine issues.
- Develops and revises procedures.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to effectively multi-task.
- Knowledge of US and global cGMP requirements.
- Must have strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
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