QC Compliance Lead

About the role

The QC Compliance Lead is an integral part of the Curia team, contributing to our success by conducting investigations to find root cause in the QC lab, drive compliance in the lab through periodic walkthroughs, measure and maintain QC lab compliance metrics, assess impact for applicable change controls, and ensure lab OOS, deviations, and other QMS records are in a compliant state. The laboratories test chemical intermediates, raw materials, APIs, and stability of those products.

This role demonstrates expertise in both the theoretical and practical aspects of analytical chemistry, root cause analysis, corrective and preventive action plans, effectiveness checks as required, and QC lab inspection readiness. Investigations are conducted in a timely manner to support key products within Curia. A key component of performance evaluation will be based on Right First-Time execution, timeliness, and the ability to effectively identify root causes, conduct thorough investigations, and implement appropriate corrective and preventive actions (CAPAs) within laboratory operations. This role is also accountable for maintaining compliance and minimizing the risk of critical audit or inspection observations.

Responsibilities

• Establish and maintain compliance standards within the QC lab.
• Work with a team to meet required QC investigation deadlines in a proficient manner, while driving to root cause and identifying the appropriate corrective and preventive action.
• Conduct and document investigations as needed, while also working with customers as required. All investigations will follow procedures in accordance with cGMPs.
• Develop and implement QC lab inspection readiness plan.
• Maintain metrics for the laboratories to identify CAPA opportunities including analyst error rate, equipment failure rate, and test method issues.
• Work with the team to develop investigation strategies to meet customer commitments and requirements.
• Provide investigation updates to cross-functional areas and management, as required.
• Develop expertise in documenting investigations and create templates for ease of reference and consistency.
• Recommend and implement methods to increase the quality of products and/or services.
• Perform periodic walkthroughs, identify any potential themes, and drive systemic CAPAs working with the QC supervisors and the QC manager.
• Trend QC lab errors and implement holistic CAPAs for improvement.
• Update analytical methods, procedures, and training modules when required.
• Identify CAPAs and update training modules to reduce analyst error rate.
• Establish new and improved ways to perform the job by challenging established procedures.
• Work independently and with the QC team as the primary investigator on all critical laboratory-related investigations.

Requirements

• Bachelor’s Degree in Chemistry or related field.
• Minimum of 6 years’ experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate.
• Investigations experience including root cause analysis, writing, and CAPA identification.

Preferred Qualifications

• Advanced Degree.
• Investigations experience in a laboratory setting.
• 8 years’ experience in a cGMP QC environment.
• Other pertinent training/courses.

Skills

• Broad knowledge of cGMP, FDA and international regulations, Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
• Knowledge of pharmaceutical processes.
• Excellent communication and organizational skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
• Proficient in building consensus, negotiating, and escalating issues.
• 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 professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to tasks such 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 deal with several abstract and concrete variables.
• Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems.

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.

Pay

Pay Range: $108,000 - $134,838. Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee is frequently required to sit; use hands to finger, handle, or feel; and reach with hands and arms.
• The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals.
• The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation; and vibration.
• The noise level in the work environment is usually moderate.