Senior Quality Control Specialist
The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations, and RNAi Early Development professionals at our Boulder, Colorado facility and collaborates closely with teams in Lexington, Massachusetts.
About the role
The Senior QC Specialist will assist with management and oversight of QC testing and reporting performed at Contracted Manufacturing and Testing Organizations. This includes testing and ongoing stability of unique API starting materials, Drug Substance, and Drug Product. The role provides QC support to Development, CMC, Operations, QA/QC, and Regulatory Affairs departments for clinical trial materials and commercial products.
Reports to the Quality Control Manager.
Responsibilities
- Demonstrate technical proficiency in analytical methodology and ensure quality control activities adhere to regulatory and internal requirements, cGMP, and ICH compliance.
- Create, revise, review, and approve protocols, supporting analytical data, and reports for method validation, testing, and release of GMP starting materials, intermediates, Drug Substances, and Drug Products.
- Serve as QC lead on analytical project teams and product operational teams.
- Conduct or support investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results.
- Write and revise SOPs, technical protocols, change control, and other quality-related reports.
- Work with the Quality management team to continuously improve the quality, compliance, and efficiency of QC operations.
- Effectively communicate internal issues related to performance, processes, and procedures.
- Act as a self-starting problem solver who drives results through high compliance and a positive work style.
Requirements
- BS/BA in a science-related field or equivalent experience with 4+ years of related Quality Control experience in biotech or pharmaceuticals, particularly in a GMP environment.
- Ability to perform analytical methods and interpret/trend stability data, including but not limited to:
- Chromatography (IP-RP-UPLC/SAX-HPLC/GC)
- Mass Spectrometry, FTIR, metals testing, residual solvents, vapor pressure, freezing point, osmolality, UV, pH, endotoxin, sterility, and bioburden.
- Knowledge of FDA cGMP regulations, ICH and FDA Guidances for Industry, Compendial requirements, and other-country regulations and standards.
- Expertise in data analysis, including reviewing, reporting, and trending data.
- Strong problem-solving and analytical skills.
- Ability to work independently with minimal supervision, interact with staff at all levels in a fast-paced environment, and remain flexible, proactive, resourceful, and efficient under pressure.
- Excellent written and verbal communication skills, strong negotiation and decision-making abilities, and keen attention to detail.
- Strong organizational skills with the ability to handle multiple tasks in a fast-paced environment.
Pay
The base compensation range for this position is $127,500 to $155,400. Base compensation is determined based on several factors. This position is also eligible for a company bonus based on individual and company performance.
Benefits
- Long-term incentive compensation and/or company vehicles (depending on position level or other factors).
- Medical, dental, and vision coverage.
- Life insurance and disability insurance.
- 401(k) savings plan.
- Flexible spending accounts.
- Employee assistance program.
- Tuition reimbursement program.
- Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.
- Paid time off pursuant to the company’s sick time policy, flexible vacation policy, and parental leave policy.