• Job Description

  Req#: R0011315

  The Opportunity

  QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

  Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

  The Role

  As we continue to grow as QuidelOrtho, we are seeking a Lead Production Chemist . The Lead Production Chemist is responsible for coordinating chemistry manufacturing activities which may include but are not limited to the preparation of buffers, assay reagents, standards and controls, complexes and conjugates, and antibody purification. Responsible for ensuring that employees follow all associated QSR and ISO regulations, manufacturing instructions, operating procedures and corporate policies.

  This position will be located onsite in San Diego, CA.

  The Responsibilities

  Daily Responsibilities:

  • Carries out duties in compliance with established business policies.

  • Develops the weekly production schedule and allocates labor based on skill level.

  • Coordinates all chemistry manufacturing activities including labor and material allocation so that production standards are met. Ensures the accuracy of material and labor transactions into LN.

  • Ensures adherence to the daily production schedule and ensures that production goals are obtained. Ensures timely start-up and shutdown.

  • Effectively communicates with all support groups (inventory, quality control, planning and management).

  • Complies with all QSRs.

  • Ensures that all manufacturing documents are reviewed and completed in an accurate and timely manner.

  Leadership Responsibilities:

  • Responsible for training and coaching employees to achieve compliance to all QSR and ISO regulations, manufacturing instructions, procedures, and company policies.

  • Coordinates and conducts staff training as appropriate. Ensures that training records are accurately maintained and current.

  • Responsible for maintaining department attendance records and reviewing employee time cards for accuracy.

  • Identifies and acts upon issues affecting departmental performance, Quality standards, and product quality.

  Additional Responsibilities:

  • Assists with the transfers of new products to manufacturing including validation of equipment and/or processes.

  • Manufactures products within QSR’s.

  • Initiates document and procedural changes utilizing the ECO system.

  • Additional tasks and/or projects as required.

  The Individual

  Required:

  • B.S./B.A. Life/Applied Sciences or equivalent experience and minimum of 6-8 years of related work experience in a GMP environment.

  • Demonstrated familiarity with the products and processes utilized in Chemistry Manufacturing

  • Laboratory Skills

  • Ability to coordinate schedule requirements of all processes performed in the department.

  • Familiar with the products and processes utilized in Chemistry Manufacturing

  • Proficient in data analysis, data summary, and presentation

  • Computer Skills

  • Basic algebraic, statistical and mathematical skills

  • General computer knowledge and experience with EXCEL, Word, and equivalent programs

  • Advanced working knowledge of LN

  • Leadership Skills

  • Demonstrates consistent and sound judgment.

  • Good organizational skills

  • Must demonstrate knowledge of internal customer/supplier relationships in decision making.

  • Good interpersonal skills

  • Good verbal and written communication skills

  • Knowledge of QSR’s and ISO 9001

  • Capable of running area in absence of supervisor

  • Identify and articulate complex problems and assume a coaching role to less experienced personnel.

  • Demonstrates maturity and good judgment in conflict resolution.

  • Make decisions related to tasks at hand with an understanding of implications and effects.

  • Utilizes excellent prioritization skills and comprehensive knowledge of the area to facilitate daily operations. Demonstrates understanding of internal customer/supplier relationships.

  Preferred:

  • Demonstrated leadership capabilities including 2 years of experience in a lead capacity.

  The Key Working Relationships

  Internal: QC, inventory control, planning, facilities.

  External: Vendors, Suppliers and contractors

  The Work Environment

  The work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

  Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted

  Essential functions are subject to change as other duties may be assigned.

  Salary Transparency

  The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $64,300.00 - 118,000.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

  EEO

  QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com

  #LI-AH1

  
  

• About the company

  Ortho Clinical Diagnostics is an in vitro diagnostics company that makes products and diagnostic equipment for blood testing.

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