QC Analytical Chemist I

Description

Key Responsibilities

• Safety & Compliance: Maintain personal accountability for a safe work environment by following all EHS procedures, participating in safety training, and proactively reporting incidents or unsafe conditions. You will ensure all work areas remain clean and compliant with federal, state, and local regulations while contributing to continuous improvement initiatives. 
• Analytical Testing: Perform QC testing of drug substances and products using HPLC, UV/VIS, KF, Melting Point, and FTIR instrumentation, following both established and emerging methodologies.
• Method Development Support: Assist in project development to create novel analytical methodologies for product analysis.
• Validation Studies: Support the design and execution of protocols for method validation studies.
• Stability Testing: Execute accelerated and real-time stability protocols for internal and client-specific products.
• Laboratory Stewardship: Maintain and audit calibration and qualification records for laboratory instrumentation, equipment, and supplies.
• Product Release Collaboration: Partner with the technical team to facilitate the pre-approval and release of manufactured and resale products based on set specifications.
• Systems Integration: Collaborate with QC, QA, and Technical departments to establish product specifications and technical data sheets within the ERP system.
• Technical Troubleshooting: Support technical teams in resolving complaints and provide technical guidance to the packaging and warehouse departments as required.
• Operational Agility: Perform additional duties of similar complexity to support laboratory and business needs.
• Other duties as assigned by Quality Manager.

Skills, Knowledge and Expertise

• Education: Bachelor’s degree in Chemistry is required.
• Alternative Education: A Bachelor’s degree in a related scientific discipline (e.g., Biochemistry, Chemical Engineering) will be considered when paired with relevant industry experience.
• Experience: 1–3 years of experience in a cGMP-regulated environment, such as the pharmaceutical or personal care industries, is preferred.

• Analytical Instrumentation: Familiarity with FTIR, HPLC, and UV/VIS is preferred; specific experience with Empower software is a significant plus.
• Regulatory Compliance: Solid foundational knowledge of cGMP, CFR, and ICH guidelines.
• Analytical Problem Solving: Ability to define problems, collect and interpret data, and draw valid, fact-based conclusions.
• Project Management: Proven ability to manage multiple projects, prioritize workflow, and consistently meet deadlines.
• Strategic Mindset: Strong organizational skills with the ability to balance immediate laboratory needs against long-term operational goals.
• Collaboration: Ability to work effectively as an independent contributor while successfully collaborating within various teams and committees.

Benefits

• Base Salary Range: $66,000 to $99,000 per year. 
• Note: Actual base wage will be determined by candidate experience, skillset, and internal equity.
• Performance Bonus: This position is eligible for an annual bonus based on both individual achievements and company performance metrics.

• Insurance: Comprehensive Medical, Dental, and Vision insurance plans.
• Financial Protection: Company-provided Life and AD&D insurance, along with Short-term and Long-term Disability coverage.
• Support: Employee Assistance Program (EAP) providing confidential counseling and resources.

• Immediate Vesting: Eligibility begins the first day of the month following your hire date.
• Employer Match: 100% match on the first 3% of employee contributions.
• Tiered Match: An additional 70% match ($0.70 on the dollar) on contributions between 3% and 6%.

• Vacation: 120 hours annually (pro-rated based on hire date), with increases based on tenure as outlined in the Employee Handbook.
• Sick Leave: Provided in accordance with the Massachusetts Earned Sick Time Law.
• Company Holidays: 9 paid holidays per calendar year.