FSP - QC Reviewer: Small Molecule

Key Responsibilities

• Change Control Management: Owning and driving change controls from initiation through closure, including writing and managing change control records, coordinating with SMEs, driving timelines, actions, and deliverables, facilitating meetings, and tracking progress.
• QC Support: Reviewing QC data and documentation, supporting quality system activities, assisting with report writing and documentation reviews, and ensuring compliance with applicable GDP and GMP requirements.

Skills

• Strong written and verbal communication skills
• Excellent organizational and project management skills
• Ability to manage timelines and follow up on action items
• Ability to work independently and drive cross-functional activities to completion
• Detail-oriented with strong documentation skills

Education and Experience

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar, with 2+ years of relevant experience OR Master's degree, with 2+ years of relevant experience.

Preferred Experience:

• QC review and data review experience
• Experience with change control and/or change management
• Familiarity with quality systems processes and documentation
• Experience writing reports, summaries, and technical conclusions

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Pay and Schedule

The salary range estimated for this position based in California is $67,699.00–$80,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.