- Ensures subordinate supervisors and professionals adhere to defined internal controls. Manages systems and procedures to protect departmental assets. Responsible for developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.3.
- Responsible for optimization and operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training. Develops, implements, and maintains quality control systems in accordance with cGMP requirements. Manages all aspects of Quality Control, in support of and in full compliance with established cGMP and company requirements.4.
- Develop staff to improve individual and departmental performance. Department oversight of manufacturing support testing for multiple projects and related stability studies.5.
- Oversight of assay verification, qualification, validation, and tech transfer activities. Verification of maintenance, calibration, and qualification of laboratory equipment. Assist in troubleshooting equipment malfunctions, assay system suitability failures, assay deviations, CAPAs, and out of specifications investigations. Coordinate instrument preventive maintenance and validation activities.6.
- Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification Reports, and Stability ProtocolsQualifications:Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment.
-
Quality Manager
Found in: Lensa US 4 C2 - 3 days ago
SpiTrex - 3D Carlsbad, United StatesJob Description · Job Description Salary: $85,000 to $145,000 · Ready to Transform Your Career? Join SpiTrex 3D · Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high ...
-
Project Quality Manager
Found in: Lensa US 4 C2 - 4 days ago
K2 Staffing, LLC Carlsbad, United StatesSummary · To lead, perform or assist in a variety of quality control activities in accordance with applicable company standards, Site Specific Quality Management Plan and approved contract documents. Our clienthas many upcoming projects that require specialized personnel with he ...
-
Project Quality Manager
Found in: Lensa US 4 C2 - 1 day ago
K2 Staffing Carlsbad, United StatesJob Description · Job Description · Summary · To lead, perform or assist in a variety of quality control activities in accordance with applicable company standards, Site Specific Quality Management Plan and approved contract documents. Our client has many upcoming projects tha ...
-
Project Quality Manager
Found in: ZipRecruiter Test10S US C2 - 2 days ago
K2 Staffing Carlsbad, United StatesJob Description · Job DescriptionSummary · To lead, perform or assist in a variety of quality control activities in accordance with applicable company standards, Site Specific Quality Management Plan and approved contract documents. Our client has many upcoming projects that requ ...
-
Senior Manager, Quality Assurance
Found in: Lensa US 4 C2 - 6 days ago
Ionis Carlsbad, United StatesIonis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antise ...
-
Regional Outside Sales Representative
Found in: SonicJobs Direct Apply US - 2 days ago
McCoy's Building Supply Carlsbad, United States Full timeJob Description · Time Type: · Full timeRole Details: · Time Type: Full TimeStarting Pay: · Job Location: This position will cover our Eastern New Mexico Area Locations · SUMMARY · Sells building materials and/or maintenance supplies to builders, businesses and industrial establ ...
-
Software QA Manager
Found in: Zoho Direct Apply - 2 days ago
Talentry Carlsbad, United StatesThis is a remote position. · Software QA Manager · Direct hire. Carlsbad, CA (Remote) · 110-125k. US Citizen or Green Card (No EAD/OPT) · Talentry is looking for an experienced Software Quality Assurance Manager to ensure the quality, functionality, and compliance of our client's ...
-
Data Reporting and Visualization Analyst
Found in: Zoho Direct Apply - 2 days ago
Talentry Carlsbad, United StatesThis is a remote position. · Data Reporting and Visualization Analyst · Carlsbad, CA (Remote Possible). Direct Hire. · 65-75k. US Citizen or Green Card only (no EAD/OPT) · Talentry is looking for a professional who can take data and develop meaningful and impactful visualizations ...
-
Cook III
Found in: Culinary Agents US C2 - 3 days ago
Four Seasons Residence Club Aviara, North San Diego Carlsbad, United States Full time· About the role · Four Seasons Residence Club Aviara is looking for a Cook 3. The Cook 3 is a key player in our kitchen, preparing and executing a variety of dishes, ensuring high quality standards, and contributing to a seamless kitchen operation. · What you will do · Check th ...
-
Chef de Cuisine
Found in: Culinary Agents US C2 - 1 day ago
Wildland & Lilo Carlsbad, United States Full timeWe are the people behind Campfire and Jeune et Jolie (1 Michelin Star), two pretty great restaurants (we are biased, but it's true) in Carlsbad, CA. We are now super excited to be looking for a Chef de Cuisine for our newest restaurant, Wildland, which will be opening later this ...
-
Senior Software Quality Engineer
Found in: Appcast US C2 - 10 hours ago
Gilero Carlsbad, United StatesJob Purpose: · Responsible for directing, managing, and maintaining the development, validation and control of · software products such as embedded software, applications, and software as a medical device · (SAMD). · Duties: · Lead software verification and validation activities ...
-
Shift Manager
Found in: Talent US 2A C2 - 10 hours ago
Wingstop Carlsbad, United States Full timeWingstop - Carlsbad NM is currently looking for a full time or part time Shift Manager to join our team in Carlsbad, NM. Shift Managers keep day to day operations running smoothly by leading their teams to success. A successful Shift Manager will keep everything running smoothly ...
-
Manufacturing Manager
Found in: Appcast US C2 - 1 day ago
Bolt Medical, Inc Carlsbad, United StatesSUMMARY OF THE JOB · Responsible for overseeing all manufactured products, value-added services, and manages the day-to-day operations of the organization's manufacturing facilities, planning, coordinating, and directing the activities (processes) that result in finished good pro ...
-
Cyber Security Manager
Found in: Appcast US C2 - 10 hours ago
Cybernetic Search Carlsbad, United StatesIT/OT Cybersecurity Manager · Cybernetic Search have partnered with a global Biotechnology company, specialized in manufacturing and delivering innovative human therapeutics. · You will be responsible for: · Lead a team of network/infrastructure engineers, overseeing recruitment ...
-
Level II
Found in: Jobget US C2 - 2 days ago
Sutter Health Carlsbad, CA, United States Part timeSutter Health is seeking a Surgical Technician Level II for a job in Carlsbad, California. · Job Description & Requirements · Specialty: Surgical Technician · Discipline: Allied Health Professional · Start Date: ASAP · Duration: Ongoing · Employment Type: Staff · We are so glad y ...
-
Quality Engineer
Found in: Appcast US C2 - 1 day ago
Bolt Medical, Inc. Carlsbad, United StatesABOUT THE COMPANY · A medical device startup company at the transition from R&D and is working on a family of therapeutic medical devices that will save people's lives. Our company has an exciting and unique technology with clinical advantages over existing procedures. It is uniq ...
-
Field Service Engineer
Found in: Appcast US C2 - 10 hours ago
Bolt Medical Carlsbad, United StatesSUMMARY OF THE JOB · The Field Service Engineer is responsible for installation, preventative maintenance, and all other instrument services at Customer sites. This also includes providing product and technical support of equipment onsite and remotely, as well as maintaining comp ...
-
Manufacturing Supervisor
Found in: Appcast US C2 - 10 hours ago
Bolt Medical Carlsbad, United StatesDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. · RECRUITERS: DO NOT CONTACT. · SUMMARY OF THE JOB · The Manufacturing Supervisor coordinates and supervises the daily activities and sets priorities for the production team. Primarily in charge of ensuring the product ...
-
Vice President of Regulatory Affairs
Found in: Appcast US C2 - 6 days ago
SOLVD Health Carlsbad, United StatesJob Description Summary · The Vice President of Regulatory Affairs is responsible for overseeing the development and execution of the Company's Quality, Clinical and Regulatory strategies for our innovative products and related services across domestic and international markets. ...
-
Restaurant Staff
Found in: ClickTrader US C2 - 1 day ago
Wingstop - Carlsbad NM Carlsbad, United StatesWingstop - Carlsbad NM is looking for a full time or part time Restaurant Staff team member to join our team in Carlsbad, NM. The Restaurant Staff team member is responsible for customer service and commitment to excellence through meeting or exceeding hospitality and service sta ...
Quality Manager - Carlsbad, United States - Allen Spolden
Description
Job DescriptionThe Quality Control Manager is responsible for developing and maintaining Quality QC systems for the Analytical department. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy.Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and organizational goals and objectives.
Ensures subordinate supervisors and professionals adhere to defined internal controls. Manages systems and procedures to protect departmental assets.Demonstrated experience in leadership and a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
Job Responsibilities1. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy.Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and organizational goals and objectives.
2.Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data.
Ability to provide support for regulatory and client audits, as well as interact with clients.A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products which could include HPLC (MWD, DAD, ELSD, RID detection), UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, MS, Genetic Analyzer, Place Readers, Gel Imagers, etc.
Familiarity with analytical testing procedures:
AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin).Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs).Sets stretch goals and links them to strategic outcomes and business deliverables.
Strong leadership and motivational capabilities.Exercises sound judgment within defined procedures and policies to determine appropriate action.
Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them.
Ability to be self-motivated, proactive, accountable, and flexible.Ability to work well under pressure, handle multiple tasks/projects and meet deadlines.
High attention to detail, highly organized, and excellent documentation skills.
Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
RequirementsRequired Education and Experience:
Bachelor of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
A minimum of 8+ years of experience performing quality control activities in the pharmaceutical and biotech industry under GMP guidelines, with a demonstrated expertise in multiple disciplines, assays, fields.
A minimum of 5+ years of GMP operations experience in the manufacture of for drugs substances / drug products.A minimum of 3+ years supervisory experience.
Percentage of Travel:
5%BenefitsDental, Medical, Vision and 401K
