Manager, QC Lab Remediation

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 vision abilities required by this job include close vision, 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.

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 has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Other Qualifications

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Pay Range: $105,000-$131,200

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

#LI-DR1