Quality Control Scientist III

Employer
Bachem
Location
Vista, CA
Posted
Jul 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

Bachem. Pioneering Partner for Peptides

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

Job Summary:

The Quality Control Scientist III function is to perform laboratory day-today operations, guide and interact with QC and department personnel to accomplish goals and objectives as directed by the Manager of Quality Control.  Other duties include performing in-process testing, GC method validation, raw material testing, and final product testing, QC documentation and related GMP activities.

Essential Functions and Responsibilities:

  • Maintain and perform daily operations of the QC department on a daily basis in coordination with the QC Director to include testing of in-process, raw material/peptide samples and prioritizing projects
  • Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control
  • Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
  • Test and release in-process, and raw materials used in the manufacturing facility for GMP. Performing analytical testing and reviewing data for completeness and accuracy. Support method validation activities for in-process samples.
  • Receive, test and release final product peptide manufactured at Bachem
  • Write/revise specifications as necessary, performing analytical testing and reviewing data for completeness and accuracy
  • Write standard operating procedures, standard test procedures and other related GMP documentation
  • Perform QC analysis to include: GC, HPLC, Water, Mass Spec, UV, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related
  • analytical equipment used for control quality of the GMP facility.  This work may include calibration and validation of these methods
  • Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
  • Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
  • Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
  • Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
  • Support validation, and stability testing activities as needed, documentation and quality GMP procedures

Minimum Qualifications:

Required:

  • Bachelor’s Degree in Chemistry or related field
  • Minimum of 8 years’ experience in the GMP industry
  • Experience with the use of analytical techniques/ instruments, such as, Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
  • May work with hazardous materials and chemicals
  • Ability to train others in analytical methodology
  • Ability to take the technical lead working with other scientists
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment
  • May involve second shift testing activities
  • Flexibility of working hours based on business needs, may include some nights and occasional weekends

Preferred:

  • Experience with Peptides
  • Master’s degree in Chemistry or related field
  • Experience with use of Master Control

What We Offer

An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes:

  • Full range of health benefits including medical, dental, vision and long-term disability
  • 401(K) Safe Harbor Plan (3% company contribution, 100% vested)
  • iPay Incentive Plan
  • 11 Paid Company Holidays, Personal Time, Sick Leave and Vacation Time
  • Travel to Switzerland for certain key positions
  • Company sponsored events! (Summer BBQ and Holiday Party)
  • Generous product discounts

Our Values

Bachem recognizes that highly motivated and well-qualified employees are its most important asset. The competence, motivation and performance of individuals and the team are key to the development and long-term success of our business. We therefore strive to attract, retain and develop talented and committed people to all of our Group Companies. Bachem ensures equal opportunities for its employees and will not tolerate any discrimination.

Physical Requirements:

This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment.  The ability to lift up to 25 lbs. is required. 

The physical demands 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.

Environmental Conditions:

Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.