Job Description
Manager, Quality Control in Rensselaer, NY - Night shift
Summary:
The Manager, Quality Control is responsible for the oversight of the Quality Control function at the site. The Manager will oversee a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, continuous improvement, and reporting of results.
Essential job duties:
• Manage and prioritize testing and operations of quality control team(s) involving samples as well as incoming, in-process and final products
• Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Supervise a team of analysts and technicians including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
• Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
• Organize workload and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
• Drive schedule adherence discipline and RFT performance with the supervisors and analysts
• Responsible for lab inspection readiness at all times
• Responsible for customer requests related to QC items
• Ensure the team compliance on initiating deviations, completing investigations and extensions to maintain regulatory compliance
• Ensure supervisors adhere to supervisor standard work for shift huddles
• Ensure there is a shift hand off process in place to transition QC operational activities
• Manage all investigations of OOS, deviations and change control management and CAPAs within the QC function
• Oversee and perform pharmaceutical analysis to support operations
• Mentor and train team members on applicable techniques and equipment
Education, experience, certification and licensures:
Required
• Bachelor's degree in Chemistry, Analytical Chemistry or related field
• Minimum 5-8 years' experience in a GMP or GLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation
• Minimum 2 years' experience in professional management
• Experience in playing a key role in regulatory inspections
Preferred
• Advanced degree in Chemistry, Analytical Chemistry or related field
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
• Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
Other Qualifications
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
Pay Range: $106,000-$134,000
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
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. 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.
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.
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.
