Quality Control Analyst I, Raw Materials

About the role

Contributes to designing the RM inspection/sampling/testing /vendor qualification programs
Performs inspections and sampling of raw materials against established specifications.
Follows procedures and documents activities, ensuring completeness and accuracy per cGMP.
Initiates nonconformance reports for unacceptable materials, and report issues to manager.
Evaluates procedures and processes for continuous process improvement.
Maintains safe and healthy work environment by following standards and procedures.
Participates in generation of controlled documents such as SOPs, specifications, and test methods.
May perform in house raw material testing.
May collaborate with external contract testing laboratories on raw material testing and/or investigations
Supports building master data in SAP and LIMS systems.

Responsibilities

• Contributes to designing the RM inspection/sampling/testing /vendor qualification programs
• Performs inspections and sampling of raw materials against established specifications.
• Follows procedures and documents activities, ensuring completeness and accuracy per cGMP.
• Initiates nonconformance reports for unacceptable materials, and report issues to manager.
• Evaluates procedures and processes for continuous process improvement.
• Maintains safe and healthy work environment by following standards and procedures.
• Participates in generation of controlled documents such as SOPs, specifications, and test methods.
• May perform in house raw material testing.
• May collaborate with external contract testing laboratories on raw material testing and/or investigations
• Supports building master data in SAP and LIMS systems.

Requirements

• B.S. in Chemistry, Biochemistry/Biology or related areas.
• Minimum 2-4 years of experience in GMP quality control environment and familiar with raw material sampling and inspection
• Experience in raw material compendial testing is a plus.
• Understanding of GMP requirements and QC systems.
• Experience in using LIMS and/or SAP system is preferred.
• Able to prioritize effectively to deliver results within established timelines.
• Able to work independently and as part of a team.

Qualifications

• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.

Skills

• Able to negotiate, influence, and work in a matrix environment.

Benefits

The expected salary range for this role is $33.00 to $37.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

Pay

$33.00 to $37.00 per hour

Schedule

Full Time