Stability Data & Compliance Associate (Hybrid)

Tolmar-7; Windsor (CO); Hybrid; USD 36,000 - 40,000; Full time

Job summary

Tolmar is seeking a detail-oriented stability data specialist to manage Stability System II Software, stability databases, and associated records. You will requisition, label, and store samples, enter new lots, and monitor storage conditions with electronic systems.

You will audit data, write stability protocols and regulatory reports, process DCRs/PCOs, and coordinate sample transport across sites. Hybrid work may be available based on performance.

Qualifications

• Bachelor’s degree in scientific discipline, math or science.
• Two or more year’s experience in the pharmaceutical or medical device industry.
• Experience with quality or stability is desired.

Responsibilities

• Maintain Stability System II Software and stability databases.
• Requisition, label and place stability samples into appropriate storage conditions.
• Enter new lots into the Stability System II Software and stability databases.
• Pull samples at appropriate time points and deliver to QC/AD/Micro labs.
• Monitor chamber storage conditions per electronic monitoring systems and audit data for accuracy.
• Review stability data to monitor product performance and document variances.
• Print graphs and data for investigations.
• Write stability protocols and reports for regulatory submissions.
• Process DCRs and PCOs; approve PCOs after assessing impact to the stability program.
• Transport stability samples between company locations.
• Participate in annual hazardous waste training and related compliance.

Skills

cGMPs & ISO9001

Oral communication

Written communication

Organized

Attention to detail

Independent work

Team collaboration

Driver’s license

Education

Bachelor’s degree in scientific discipline

2+ years experience in pharma/medical device

Experience with quality or stability

Tools

Word

Access

Job description

Tolmar is seeking a detail-oriented stability data specialist to manage Stability System II Software, stability databases, and associated records. You will requisition, label, and store samples, enter new lots, and monitor storage conditions with electronic systems.

You will audit data, write stability protocols and regulatory reports, process DCRs/PCOs, and coordinate sample transport across sites. Hybrid work may be available based on performance.