Quality Control Scientist

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

A brief summary

 

The QC Scientist (microbiology) will manage and execute the environmental monitoring program, water and critical utilities monitoring program. Other duties include performing, QC documentation including lab notebooks and reports and related GMP activities.

 

What you will do

 

  • Perform necessary environmental monitoring procedures to include water sampling, viable and non-viable air sampling and viable surface monitoring
  • General upkeep of microbiology laboratory including monitoring of temperatures for incubators and storage refrigerators
  • Perform necessary testing for approval of vendors and qualification of necessary media used in the microbiology laboratory
  • Maintain and support the cleaning verification program by performing Total Organic Carbon testing
  • Trend microbiology data and report  back to management and QA to ensure systems are within trend                      
  • Perform endotoxin testing for final lyophilized peptide products.  The kinetic and gel clot method will both be employed
  • Write/revise standard operating procedures, and other related GMP documentation as related to the job function as necessary
  • Maintain GMP areas to ensure compliance for all requirements for control of materials.  This includes cleanliness and organization
  • Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
  • Operate, maintain and ensure calibration of equipment including, chart recorders, thermometers, analytical balance, pipette and other related equipment in microbiology lab and the GMP facility as required by job function
  • Investigate any deviation or out of specification as necessary related to Quality Control work performed as instructed by supervisor
  • Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste

 

Qualifications

 

  • Bachelor’s Degree in Life Sciences
  • Minimum 4 years’ experience in a GMP environment specializing in pharmaceutical or biotech industry
  • Use of analytical techniques / instruments, such as TOC, Endotoxin, Conductivity, etc., and computer skills
  • Develop and maintain environmental tracking and trending programs
  • Knowledge of ICH Q1 and ICH Q7, cGMP and FDA regulations
  • Experience working in a clean rooms (ISO 7 and/or ISO 8)
  • Ability to effectively organize, multitask, and work in a fast-paced environment
  • Excellent written and oral communications skills
  • Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
  • Exhibit professional interpersonal skills
  • Communicate effectively and ability to function well in a team environment
  • Exhibit detail oriented documentation skills
  • Ability to work independently and manage one's time
  • Basic computer knowledge, including Microsoft Word and Excel
  • Coordinate sampling and testing in collaboration with Quality Control and Production
  • Ability to convey to customers and regulatory agencies topics regarding micro-biology processes
  • Flexibility of working hours based on business needs, may include some nights and occasional weekends
  • Experience with Minitab and/or other statistical software (preferred)

 

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.

 

 

Base Hourly Pay Ranges:

 

Quality Control Scientist I: $24.96 - $34.31 (0+ years)

Quality Control Scientist II: $27.99 - $38.48 (5+ years)

Sr. Quality Control Scientist: $38.69 - $53.21 (8+ years)

 

 

Placement of new hires in the wage range is based on several factors including education, skill sets, experience, and training.

 

Total Rewards

 

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

 

Corporate Social Responsibility

 

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

 

Bachem Americas is an Equal Opportunity Employer

 

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

 


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