Job Description Job Title: Chemist III (Senior Staff) Laboratory Job Code: FLSA Status: Exempt Reports To: QC Supervisor Department #: Department: Quality Control Location: Cerritos, California Prepared By/Date: Incumbent: Approved By/Date: Summary: Quality Control Chemist III primarily supports, reviews, and verifies the work of technicians and Chemists I and II. They are to delegate the regular tasks of Quality Control operations to ensure proper schedule adherence as well as provide technical and operational guidance and training to subordinate staff. They may, as needed, be directly involved in testing and/or contracting necessary tests to third party laboratories of all ingredients involved with softgel production for identity, purity, strength, and composition to ensure content of finished product capsules are of the highest quality as confirmed by conformance to all established specifications before release to the customer. Essential Duties and Responsibilities include the following. Other duties may be assigned. Per compliance to cGMP, Captek SOPs, and training, thoroughly reviews and verifies Raw Material Specification and Analytical Reports, Finished Product test packets, and supporting test reports for proper, complete, and accurate documentation. Ensures proper testing and methodologies are executed respective of Captek’s quality systems. Generates appropriate and complete finished product Certificates of Analysis per product requirement and endorses upon completion of finished product test packet, verifying finished product CoA claims as accurate, true, and complete. Addresses to resolve any noted deficiencies during the review of all said test data/report. Notifies superior of unresolved issues in an appropriate and timely manner. Executes, delegates, and/or reviews, as appropriate, any and all investigations of out of specification test results obtained. Ensures that proper testing of raw materials and finished products are being carried out and completed in a timely manner, adhering to all schedules as set by Quality Control manager, confirmed by Quality Control staff and committed by self, and/or based on reasonable demand of Captek’s operational support. Thoroughly reviews all documents, test data, and reports submitted for review and endorses upon approval. As needed, assists Quality Control Manager with audits and provides Quality Control support to other Captek departments and Captek clients. Authors and reviews Quality Control related SOPS, while ensuring proper adherence to by subordinate Quality Control staff. Develops, transfers, authors and/or reviews Quality Control Test Methods, while ensuring proper execution of approved methods by Quality Control staff. Performs, as needed, Atomic Absorption Spectroscopy, High Pressure Liquid Chromatography, Ultra-Violet/Visible Absorption Spectroscopy, and wet chemistry analysis. 1 Trains other chemists and technicians and prepares, as needed, sample, solvents/reagents, and systems for testing, calculates data and results, documents the entire procedure, disposes and safely cleans up solutions in the hazardous chemicals waste (under the hood), discards all disposables in appropriate waste containers and properly and safely cleans all glassware, work-stations, and any apparatus/equipment used. Safely and appropriately uses and instructs/trains the usage of tools such as scalpels, glassware, dishes, weighing dishes, pipets, burets, volumetric flasks, ovens, furnaces, stirrers/heat-plates, ultrasonicators, baths, balances, titrators, chemically resistant containers, graduated cylinders, beakers, spectrophotometer cuvettes and permanent markers. Safely and appropriately uses and instructs/trains the usage of reagents (substance or compounds) such as water, acids and bases of varying concentration, buffers, and solvents ranging from weak to strong that are added to a system in order to bring about a chemical reaction or to see if a reaction, interaction, or separation occurs. Interacts with Microbiologists and oversees laboratory technicians, Chemists I and II. As appropriated by QC Manager, executes training matrix. Must exemplify adherence to all safety, cGMP, and Captek’s Standard Operating Procedures, particularly those of the 6 series, while keeping accountability of other QC staff to the same. All Quality Control Chemists must have the ability to be flexible, handle multiple projects simultaneously and adjust personal style to adapt to increased business pressures and work well under pressure while performing all tasks in an accurate, complete, and appropriate manner. Qualifications: 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. Education/Experience: Minimum Bachelor’s Degree; Master's degree (M. A.) or equivalent a plus; with two to ten years related experience and/or training; or equivalent combination of education and experience. Degree in Chemistry preferred. Technical Ability: Basic, Intermediate, and Advanced laboratory techniques. Language Ability: Ability to read, analyze, interpret, grasp, and explain common scientific and technical journals, concepts, as well as methods and test procedures. Ability to respond to common inquiries by co-workers, technicians and supervisory personnel as well as communicating with suppliers and collaborating with contract laboratories. Math Ability: Ability to comprehend and apply principles up to advanced calculus, modern algebra, and advanced statistical theory. As needed, ability to work with concepts such as limits, graphical and data interpretation, rings, quadratic and differential equations, and proofs of theorems. Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. 2 Computer Skills: To perform this job successfully, an individual should have knowledge of: Instrument software utilization such as for HPLC, UV-Vis, FTIR, etc. as well as Internet, Word, Excel, SysPro and UniPoint Certificates and Licenses: N/A Supervisory Responsibilities: Supervises Chemist II, Chemist I, and Quality Control Technicians 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 occasionally exposed to toxic and/or caustic chemicals such as Sodium Hydroxide, Hydrochloric Acid, Methylene Chloride, Hydrogen Sulfide Solutions, and more. There is a risk of electrical shock if proper machinery procedures are not followed as well as the dangers of possible burns from chemicals, fires and combustion reactions as well as explosions. Safe work practices and proper handling are essential to the success of this position as well as the safety of all staff members of the laboratory. The noise level in the work environment is usually moderate. Physical Demands: 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 must regularly lift and /or move up to 25 pounds. Specific vision abilities required by this job include: Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this Job, the employee is regularly required to use hands and fingers to feel and reach with hands and arms. The employee is frequently required to stand; walk; sit and talk or hear. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell. Competency: To perform the job successfully, an individual should demonstrate the following competencies: Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Demonstrates attention to detail. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Interpersonal - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings. Team Work - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Supports everyone's efforts to succeed; Recognizes accomplishments of other team members. 3 Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively and accurately; Able to read and interpret written information. Quality Management - Demonstrates accuracy and thoroughness. Diversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment. Ethics - Treats people with respect; Upholds organizational values. Support - Follows policies and procedures; Supports organization's goals and values. Adaptability - Adapts to changes in the work environment; Able to deal with frequent change, delays, or unexpected events. Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Accountability - Upholds own responsibilities while keeping others engaged with the task requested in cases of collaborative work. Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Asks for and offers help when needed. Judgment - Exhibits sound and accurate judgment; Supports and explains reasoning for decisions. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Keeps area organized and structured so as to adequately manage tasks Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. _________________________________________ Employee Signature Date __________________________________________ Human Resources Date 4