Manager, QC Lab Remediation

Location: Rensselaer

Manager, Quality Control Lab Remediation 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 Laboratory Remediation Manager is an integral part of the Curia team, contributing to our success by leading the QC lab remediation program.  The laboratories test chemical intermediates, raw materials, API's, and stability of those products.. The QC Lab Remediation Manager will drive the QC lab improvement initiatives to maintain regulatory compliance & simultaneously implement continuous improvement initiatives. The role requires assessing gaps in existing QC lab systems, identifying simple and compliant solutions and implementing the solutions for routine operations.

This role will also lead the QC lab LIMS implementation. Identify key areas of improvement and develop robust CAPA plans

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 QC lab remediation and continuous improvement

+ Work with QC supervisors and QC Manager to complete regulatory inspection and customer audit commitments in an effective and timely manner

+ Trend QC lab performance metrics, identify areas of improvement and implement robust CAPAs

+ Play a key role in QC lab inspection readiness plan

+ Perform gap assessments for Curia network regulatory inspectional observations for QC and implement CAPAs for the gap areas.

+ Develop a compliant and practical training and qualification program in the lab, develop training metrics and train the trainers

+ Perform periodic walkthroughs, identify any potential themes and drive systemic CAPAs working with the QC supervisors and the QC manager

+ Update analytical methods, procedures, and training modules to drive improvements

+ Lead QC lab LIMS implementation, will support as a key conduit between site QC operation, IT and Global Quality Systems teams in driving the Master Data development, procedural updates and UATs

+ Establish new and improved ways to perform the job by challenging established procedures.

Education, experience, certification and licensures Required

+ Bachelor's Degree in Chemistry or relevant field

+ Minimum of 5 years of relevant related work experience plus 2 years in a team leadership role.

+ Investigations experience including root cause analysis, writing, and CAPA identification

+ Good understanding of GMP requirements for QC operations

+ Previous experience managing a QC team in a commercial product GMP environment

Preferred

+ Advanced degree in Chemistry or related field.

+ Investigations experience in a laboratory setting

+ Pertinent training/courses

+ Experience in a cGMP QC environment

Supervisory responsibilities

This position does not have supervisory responsibilities.

Knowledge, skills and abilities

+ Ability to recognize what needs to be done, take action, and accomplish results

+ Strong oral and written communication skills, including effective listening

+ Demonstrated ability to effectively utilize team resources

+ Expert in cGMP, USP, EP and FDA regulations

+ Technical competence including the understanding of theory and interpretation of all lab techniques

+ Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software

+ Strong organizational skills with the ability to multi-task

+ Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

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 sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.

Specific…