Quality Control Laboratory Supervisor - New Brunswick, United States - Spectrum Chemical

Description

SUMMARY:

The Supervisor position is responsible for managing all activities associated with the daily operation of the Quality Control analytical laboratory. This includes training, mentoring, problem-solving, and prioritizing the laboratory schedule to meet production timelines. The Supervisor serves as a critical interface between the laboratory and other departments.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Direct QC team by establishing direction, distributing workload, and communicating clearly.
• Direct the daily QC workload to ensure schedule completion is consistent with production schedules while managing utilization and efficiency.
• Assure the orientation process for QC new hires and ensure compliance with all safety, GMP, and other regulatory requirements for the QC team.
• Responsible for supervising and training the teams on correcting, resolving, and closing nonconformances, out-of-specifications, and Deviations.
• Provide technical support to the QC team concerning test methods, instruments, samples, and standards.
• Develop direct reports by providing challenging tasks and assignments and provide developmental feedback.
• Develop direct reports using the PM (Performance Management) process and offer clear and constructive feedback.
• Develop a disciplined QC workforce that adheres to all procedures and Work Instruction Documents.
• Assist with external and internal customer, regulatory, and quality system audits, QAF form controls, and onboarding tasks.
• Ensure the timely completion of testing, tasks, and assignments while identifying and implementing improvements to optimize workflow, throughput, quality of work, and compliance.
• Personally, comply with all company regulatory requests while assuring/encouraging the team does likewise.
• Supervise lab personnel regarding all quality testing, including raw materials, post-pack production, and in-process checks. Schedule and balance testing and other tasks for optimization.
• Maintain calibration/verification procedures and ensure proper testing was done regarding ISO9001, ISO 14971, ISO 17025, 21CFR Part211, ICH Q7, and CGMP standards.
• Assure calibrations, standards, logbooks, and other GMP-compliant activities are performed in the laboratory.
• Provides technical assistance and information to Customers, Suppliers, Sales, and Internal departments to ensure product quality
• Manages safety and environmental regulations by ensuring that standards, policies, and procedures are adhered to in compliance with corporate, federal, state, and local requirements
• Maintain a safe working environment by cleaning and maintaining the laboratory and equipment.
• Run Quality reports in Oracle, utilizing statistical methods.
• Decisions related to batch adjustments and raw material rejections should be based on the applicable acceptance criteria, monographs, and specifications.

EXPERIENCE:

• A bachelor's Degree in Chemistry area from four a four-year college or University is required
• Knowledge of quality control lab activities and procedures, technical knowledge of Analytical Chemistry
• Experience in GMP pharmaceutical product testing and knowledge of GDP and GLP requirements
• Practical interpersonal, leadership, and organizational skills
• Knowledge of principles of applicable 21 CFR compliance, including Parts 11 and 211
• Ability to manage multi-tasks and deal with several issues simultaneously, utilizing prioritization, delegation, and personal effort in a fast-paced, high-volume environment
• Proficient in Microsoft Word, Excel, PowerPoint, and SharePoint.
• Certified Chemical Engineer, Certified Quality Engineer, and Certified Six Sigma Green Belt are preferred but not required.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the required knowledge, skill, and ability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Must have a superior understanding of the operation of analytical instrumentation, including troubleshooting and minor maintenance issues.

EDUCATION and EXPERIENCE:

The successful candidate must have a bachelors degree (B. A.) in chemistry, biochemistry, or related scientific field from a four-year College or University. In addition, 5 7 years of related experience working in a laboratory in a manufacturing or academic setting is highly preferred. Or a Masters (M.S.) Degree from an accredited four-year college or University in chemistry, biochemistry, or related scientific field with a preferred 3- 4 years experience working in a laboratory in a manufacturing or academic setting. Or a doctorate from an accredited four-year college or University in chemistry, biochemistry, or a related scientific field with a preferred 1- 3 years of experience working in a laboratory in a manufacturing or academic setting. Must have a strong knowledge of chromatographic systems utilized in the laboratory setting, such as Open Lab or Empower software.

Must have hands-on experience working on laboratory equipment like FTIR, HPLC, GC, AA, or ICP-MS.

LANGUAGE SKILLS:

Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to technical-based inquiries or complaints. Ability to make effective and persuasive presentations on technical or complex topics to top management, customers, and boards of directors. Ability to effectively interact with regulatory and other government agencies

MATHEMATICAL SKILLS:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 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.

REASONING ABILITY:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret various compendia and monographs.

CERTIFICATES, LICENSES, REGISTRATIONS:

None required for this position

PHYSICAL DEMANDS:

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, use hands to finger, handle, or feel, and talk or hear. The employee is occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, and taste or smell. The employee must regularly lift and move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform basic functions.

While performing the duties of this job, the employee is frequently at risk of exposure to fumes, airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.