Job Description

Job Title: Quality Lab Associate II, Chemistry

Provide support to Chemistry laboratory as technical Writer. Responsible for conducting Laboratory Investigations, Annual Product Reviews, trending data and errors and writing protocols and reports. Provide monthly metric reports to QA/QC management.

1. Conduct laboratory investigations with laboratory supervisors, review related data, interview personnel, recommend corrective actions and write reports. Trend errors and provide monthly reports to QA/QC management. Provide weekly status of laboratory investigation reports.
2. Conduct Annual Product Reviews, prepare and evaluate data trends and provide an expert advice to teams involving in the troubleshooting and program solving activities.
3. Prepare, review, and revise, as required, SOPs, protocols, reports, and other appropriate documentation for proper functioning of the department. Assists and writes protocols for method evaluations and other studies.
4. Assist in training staff and assures training requirements are met and records are up to date.
5. Assist in audits by providing answers to questions regarding laboratory investigations posed by any inspector.
6. Participate in pro-active functions that impact the lab operations and production, increase efficiency, solve problems, generate cost savings and improve quality.
7. Participates in weekly investigation meetings with QA/QC management.
8. Exposure to confidential/sensitive information and policies/procedures.

Bachelor Degree in Chemistry or related science with Analytical Chemistry or Laboratory coursework, with 5 to 7 years’ experience in a cGMP Chemistry Laboratory along with laboratory investigations.

1. Knowledgeable of quality control chemistry operations in the pharmaceutical industry
2. Exceptional technical writing skills.
3. Proficient with Microsoft Word and Excel.
4. Exceptional organizational skills and ability to plan and implement resolutions to technical problems. Familiarity with auditing techniques, interpreting regulations and quality systems.
5. Understand scientific strategies and be able to invent new methods or new avenues of investigation.
6. Good interpersonal/communication/influencing/negation skills.
7. Good project management skills.
8. Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.