QC Compliance Lead

Curia • City of Rensselaer, NY

8h • $105,000 - $130,000

About The Position

QC Compliance Lead in Rensselaer, NY

Build your future at Curia, where our work has the power to save lives 

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.

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 walk throughs, measure and maintain QC
lab compliance metrics, assess impact for applicable change controls, ensure lab
OOS, deviations and other QMS records are in a compliant state.  The
laboratories test chemical intermediates, raw materials, API’s, 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.  The investigations are to be 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.

To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are representative
of the knowledge, skill, and/or ability required. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential
functions.

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
• 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 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 deal with several abstract and concrete variables
• Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems

Nice To Haves

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

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 cGMP’s.
• 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 an expertise in documenting investigations and create templates to use 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 CAPA’s 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.

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
• And more!

What This Job Offers

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