Quality Control (QC) Analyst I, II, & III

About the role

The Quality Control Analyst will support late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.

Responsibilities

• Analytical testing to support product in-process, release, and stability programs.
• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Requirements

• Minimum Qualifications: A 4-year Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field.
• Previous experience for QC I (0 to 2 years or more), QC II (2 to 5 years or more), and QC III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Working knowledge of cGMP regulations (21 CFR210/211/820).
• Strong background in small molecule and protein chemistry and experience in troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.

Preferred Qualifications

• Specialized Knowledge and Skills: QC I & II Analyst - Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. Previous experience supporting regulatory inspections (e.g., PAI). Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.
• QC III Analyst - In-depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation. Strong communication skills, both written and verbal. Must be detail-oriented. Must be able to effectively manage time to complete assignments. Excellent computer skills in Microsoft Office applications.

Compensation

• QC I Analyst - Base Salary Range: $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus.
• QC II Analyst - Base Salary Range: $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus.
• QC III Analyst - Base Salary Range: $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus.

Benefits/Perks

• Medical Insurance - Aetna
• Prescription Drug Converge | RxVirtual
• Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSPL
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
• Legal Services
• ID Theft Protection
• Travel Assistance
• Value Added Benefits & Services
• Health Advocate
• Life Assistance Program (LAP)
• Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Working Environment/Physical Requirements

• Typing, desk work, and plant auditing.
• Able to read, write, and understand English.
• Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.