Quality Control Scientist II - Micro Biology
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.
The QC Scientist II, Micro Biology 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.
Essential Functions and Responsibilities:
- 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
- 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
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
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.
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.
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.
The above statements reflect the general duties/responsibilities necessary to identify the type and level of the position and are not intended to set forth all of the specific requirements of the position. Bachem is an at-will employer and as such reserves the right to revise or change job duties and responsibilities as the need arises and either party may terminate the employee/employer relationship at any time with or without cause. This position summary does not constitute a written or implied contract of employment.