QC Compliance Lead

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

1. Establish and maintain compliance standards within the QC lab
2. 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.
3. Conduct and document investigations as needed, while also working with customers as required. 
4. All investigations will follow procedures in accordance with cGMP’s.
5. Develop and implement QC lab inspection readiness plan
6. Maintain metrics for the laboratories to identify CAPA opportunities including, analyst error rate, equipment failure rate, and test method issues.
7. Work with the team to develop investigation strategies to meet customer commitments and requirements.
8. Provide investigation updates to cross functional areas and management, as required. 
9. Develop an expertise in documenting investigations and create templates to use for ease of reference and consistency.
10. Recommend and implement methods to increase the quality of products and/or services.
11. Perform periodic walkthroughs, identify any potential themes and drive systemic CAPAs working with the QC supervisors and the QC manager
12. Trend QC lab errors and implement holistic CAPAs for improvement
13. Update analytical methods, procedures, and training modules when required.
14. Identify CAPA’s and update training modules to reduce analyst error rate
15. Establish new and improved ways to perform the job by challenging established procedures.
16. 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

1. Broad knowledge of cGMP, FDA and international regulations, Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH)
2. Knowledge of pharmaceutical processes
3. 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
4. Proficient in building consensus, negotiating and escalating issues
5. Ability to meet deadlines and work under pressure with limited supervision
6. Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently 
7. Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations 
8. Ability to write reports, business correspondence, and procedure manuals
9. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
10. 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
11. Ability to define problems, collect data, establish facts, and draw valid conclusions
12. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
13. Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems

Supervisory responsibilities

This position does not have supervisory responsibilities.

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.

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.

Pay Range: $108,000 - $134,838

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.

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