Compliance Specialist II (Manufacturing/Quality) 1st Shift

Pyramid Consulting, Inc; Framingham (MA); On-site; USD 48,216 - 60,614; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

A consulting firm specialized in compliance is seeking a Compliance Specialist II in Framingham, MA. In this role, you will conduct audits, establish quality standards, and ensure manufacturing compliance with regulations. Candidates should have 2+ years in GMP and experience with inspections. A Bachelor’s Degree is required. This position offers a pay range of $35 to $44 per hour and includes health benefits and a 401(k) plan.

Qualifications

• Minimum of 2 years of experience in GMP, focusing on quality or manufacturing.
• Must have inspection experience for both in-process and finished goods.
• Experience in investigating deviations.

Responsibilities

• Perform audits to ensure compliance with manufacturing procedures.
• Establish quality standards, auditing requirements, and test methods.
• Conduct internal audits of manufacturing processes.

Skills

GMP experience

Inspection experience

Deviation investigation

SAP experience

Data acquisition in LIMS

Quality standards knowledge

Education

Bachelor's Degree

Tools

SAP

LIMS

Veeva

Job description

Compliance Specialist II (Manufacturing/Quality) 1st Shift

Immediate need for a talented Compliance Specialist II located in Framingham, MA (Onsite). This is a 12‑month contract with long‑term potential.

Pay Range: $35.00/hr - $44.00/hr

Employee Benefits: health insurance (medical, dental, vision), 401(k) plan, paid sick leave (depending on work location).

Responsibilities

• Perform audits necessary to ensure compliance of manufacturing procedures to in‑house specifications and government regulation.
• Establish auditing requirements, quality standards, and test methods in accordance with regulations and relevant quality requirements.
• Conduct internal audits of manufacturing processes to ensure compliance.
• Conduct review of testing results.
• Review documents and complete inspection of returned goods.
• May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.
• Interpret complex, explicit documentation to ensure quality standards and compliance.
• May provide training to new employees.
• Work under very general supervision.
• Work is reviewed for soundness of judgment and overall adequacy and accuracy.
• Contribute to the completion of organizational projects and goals.
• Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
• Frequent internal company and external contacts.
• Represent organization on specific projects.

Qualifications

• Minimum of 2 years of experience in GMP, can be in quality, manufacturing.
• Must have inspection experience process, previous experience inspecting in‑process and finished goods.
• Experience investigating deviations.
• Minimum of 3 – 6 years of experience.
• Minimum Education: Bachelor’s Degree.
• Nice to have: SAP experience, managing complaint or complaint investigation, or experience acquiring data in LIMS, Veeva.
• Team will work last week of December during year‑end shut‑down.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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