Manager, Quality Control

Curia Global

  • Camarillo, CA
  • Permanent
  • Full-time
  • 2 months ago
Job Category: QualityJob Description:Manager, Quality Control, Camarillo, CABuild your future at Curia, where our work has the power to save livesCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offer
  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401K program with matching contributions
  • Learning platform
  • And more!
Summary:The Manager of Quality Control is responsible for overseeing all operations within the Quality Control Laboratory. This role encompasses a wide range of duties, including personnel management (hiring, conducting performance reviews, managing performance, scheduling, etc.), budget preparation and management, and ensuring the lab is audit-ready for both regulatory bodies and customers. The Manager will also be responsible for developing and maintaining departmental metrics, representing the department in various internal and external meetings, and collaborating with both internal stakeholders and external customers to deliver exceptional service. Additionally, this position involves fostering a culture of continuous improvement, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), and leading initiatives to enhance laboratory efficiency and effectiveness.Essential Duties and Responsibilities:
  • Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities.
  • Mentor chemists and analysts
  • Write, review, revise and approve:
  • Standard Operating Procedures (i.e. Laboratory Procedures)
  • Project Progress Reports
  • Project Timelines
  • Acceptance Methods
  • Test Data (Summary Results)
  • Conduct and appropriately document laboratory investigations
  • Write, review and direct the execution of analytical protocols
  • Manage computer system validation (CSV) activities for analytical equipment/instruments
  • Demonstrate success in technical proficiency, scientific creativity, independent thought, and collaboration with others.
  • Demonstrate analytical problem solving skills
  • Conduct data analysis using a wide range of scientific and statistical tools
  • Troubleshoot and resolve complex issues
  • Demonstrate high ethical standards
  • Possess analytical instrument trouble shooting skills
  • Demonstrate excellent oral and written communication skills
  • Demonstrate both multi-tasking ability and the ability to effectively prioritize projects
  • Demonstrate the ability to observe and communicate trends and develop “continuous improvement” plans.
  • Act as a technical liaison with customers to define objectives of projects and provide written/verbal reports on progress.
  • Possess analytical instrument repair knowledge and ability.
  • Read/interpret SOPs to ensure compliance
  • Maintain a robust training program designed to demonstrate proficiency in analytical techniques. MEnsure analysts maintain up to date trainings
  • Other duties as assigned
Education and/or Experience:
  • Bachelor's degree in in Science, Chemistry, Biology or related field of study
  • Minimum of five (5) years in Analytical Chemistry, Quality Assurance or Regulatory Compliance Management
  • Minimum of two (2) years in a leadership role
  • Minimum of five (5) years in an aseptic/sterile product facility, preferred
Supervisory Responsibilities: This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.Language Skills: The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.Mathematical Skills: Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Computer Skills: The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.Other Skills and Abilities:
  • Leads with integrity and respect
  • Provides guidance, coaching, and mentorship to team members
  • Demonstrates business acumen
  • Fosters a collaborative and positive work environment
  • Champions change
  • Coaches and Develops
  • Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
  • Demonstrates strong attention to detail
Other Qualifications:
  • Must pass a background check
  • Must pass a drug screen
  • May be required to pass Occupational Health Screening
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 essential physical demands will vary for each Curia position.All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.Work Environment:The work environment characteristics, described below, 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.The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.All environments may be subject to working with or being exposed to cleaning agents.Education, experience, location and tenure may be considered along with internal equity when job offers are extended.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. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.#LI-MM2

Curia Global