QC Compliance Lead

Location: Rensselaer

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.

We proudly offer

* 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!

Position overview

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.

Essential job duties

* 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.

Education, experience, certification and licensures Required

* 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

* Advanced Degree

* Investigations experience in a laboratory setting

* Other pertinent training/courses

* 8 years' experience in a cGMP QC environment

Knowledge, skills and abilities

* 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…