Quality Control Analyst III

Curia • Camarillo, CA

12h • $85,000 - $106,500 • Onsite

About The Position

The Quality Control Analyst III is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• Bachelor's Degree in Chemistry or related field and 5+ years related work experience; OR Master’s Degree in Chemistry or related field and 3+ years related work experience; OR PhD in Chemistry or related field and 1+ years related work experience
• Experience working in cGMP or GLP pharmaceutical industry environment
• Willing to work flexible hours (nights and weekends), as-needed (overtime eligible)
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to meet deadlines and work under pressure with limited supervision
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedures
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and handle several abstract and concrete variables
• Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain gowning certification
• May be required to obtain and maintain media qualification

Responsibilities

• Perform complex testing and data evaluation, such as HPLC, ELISA, etc.
• Troubleshoot equipment issues promptly and communicate resolutions to management
• Participate in or assist with test method validations
• Evaluate data for trends
• Support and/or investigate OOS events by performing thorough root cause analyses, assessing potential product impact, and implementing appropriate CAPAs
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at outside testing labs, raw materials, etc.
• Maintain a detailed and accurate recording of activities and results
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries
• Perform risk assessment as needed
• Write/revise test methods, standard operating procedures, etc.
• Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
• Support equipment upkeep
• Prepare and order supplies, as necessary
• Enter data into relevant data management systems and perform tracking and trending of data. Compile data and provide/present data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Collaborate with cross-functional departments to coordinate testing, scheduling needs, and prioritization
• Lead departmental projects and participate in cross-functional teams, including continuous improvement initiatives and new customer project teams
• Lead the stability program, including management of test points, reporting of data, and investigations of out of specification or aberrant stability results

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Senior