Summary: Quality Control Manager is responsible for the whole oversight of the Quality Control department. They are to appropriate, delegate, and Quality Control operations and related task to ensure company’s full Quality Control support as well as provide technical and operational guidance and training to subordinate staff and other departments within the organization. They will need to strategically ensure to successful performance of the Quality Control group in properly evaluating and testing raw materials, in-process materials, finished products, and any other testing needs, as well as ensuring technical review, cGMP compliance as relating to laboratory operations, and customer technical support. The individual will need to review the system and the output of the Quality Control group for compliance to company policies and the quality requirements required in the dietary supplement industry.
Essential Duties and Responsibilities: include the following, other duties may be assigned. Per compliance to cGMP, Captek SOPs, and training, thoroughly reviews and verifies Quality Control systems and operations within the department as well as in support of the organization.
- Oversees and technically review Captek’s sanitation program and systems.
- Represents Captek’s Quality Control operations as needed in customer and regulatory audits, meetings, qualifications, and/or any other such required instances.
- Oversees that all proper SOP’s testing methods, documentation, training, qualifications and programs, investigations, compliance, and system optimization as relating to the Quality Control group are in place and are appropriately maintained.
- Verifies systems are in place, effective and adhered by the Quality Control department as relating to raw materials, in-process materials, finished products, test requirement, and any other testing, qualification and technical needs for successful quality control support of Captek Softgel International operations.
- Oversees that proper testing and methodologies are executed respective of Captek’s quality systems.
- As necessary, thoroughly reviews completed and/or prepared Quality Control documentation and dispositions or endorses appropriately upon verification of documentation as accurate, true and complete.
- Oversees that proper testing of raw materials and finished products are being carried out and completed in a timely manner, adhering to all set schedules, confirmed by Quality Control Staff and committed by self, and/or based on reasonable demand of Captek’s operational support.
- Authors and/ or reviews Quality Control related SOPS, while ensuring proper adherence to by subordinate Quality Control Staff.
- Develops, transfers, authors, oversees and/or reviews Quality Control Test Methods, while ensuring proper execution of approved methods by Quality Control staff.
- Maintains a strong conceptual understanding of the processes, procedures, and scientific concepts practiced in the Quality Control laboratory. Provides Quality Control staff with respective guidance and support.
- As necessary, safely and appropriately user and instructs/trains the usage of tools such as scalpels, glassware, dishes, weighing dishes, pipets, burets, volumetric flasks, ovens, furnaces, stirrers/heat-plates, baths, balances, titrators, chemically resistant containers, graduated cylinders, beakers, spectrophotometer cuvettes and permanent markers.
- As necessary, safety and appropriately uses and instructs/trains the usage of reagents (substance or compounds) such as water, acids and bases of varying concentrations, 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.
- Must exemplify adherence to all safety, cGMP and Capteks Standard Operating Procedures, particularly those of the 6 series, while keeping accountability of other QC staff to the same.
- Quality Control Manager must have the ability to be flexible, handle and support multiple projects simultaneously and adjust personal style to adapt to increase business pressures and work well under pressure while performing all tasks accurate, complete and appropriate manner.
- Quality Control Manager must have the ability to communicate effectively inter- and intra- departmentally matters as pertaining to Quality Control.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed 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 preferred; with a minimum of seven years related experience and/or training, of which a year to two of managerial experience a plus, or equivalent education, experience, background and assessed aptitude and capacity. Degree in the sciences as relating to Microbiology and/or 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 inquires by co-workers, technicians and supervisory panel as well as communicating with suppliers, customers and collaborating with contract labs.
Captek Softgel International, Inc. (CSI) is a privately-owned, FDA registered and audited, GMP-certified, full service contract manufacturer of custom dietary supplement formulations. CSI features high efficiency encapsulation lines operating 24/5, capable of producing over 3 billion softgels annually. The facility encompasses approximately 85,000 square feet of production, analytical laboratory, pilot laboratory and warehousing space. Captek fully complies to FDA cGMP and has been independently certified by NSF International.
Role: QC Manager
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