Quality Assurance Specialist III
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 Quality Assurance Specialist III fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.
Essential Functions and Responsibilities:
· GMP compliance improvements
· Perform GMP audits for internal operations as needed
· Work closely with other functions to close out deviations, CAPA and product complaints
· Provide cGMP compliance guidance to other departments
· Writing new and revising current standard operating procedures (SOPs) specifications, etc.
· Reviewing all GMP documentation, including BPRs and monitoring data
· Reviewing trending data
· Provide support to customer and regulatory audits
· Recommends and implements new policies and procedures to improve existing processes and products
· Writing and reviewing validation protocols, reports and master plans
· Problem resolutions with GMP systems
· A Bachelor’s Degree in Science or related field and a minimum of 5 years’ experience in the GMP / Manufacturing setting or
· Associates Degree in Science or related field and a minimum of 7 years’ experience in the GMP / Manufacturing setting
· 5 years’ work experience in GMP manufacturing
· Experience in GMP manufacturing environment, Quality Assurance and Quality Control
· Experience with GMP document control, validation, qualification and calibration
· Ability to work in ISO7 and ISO8 control environment and support real time batch record review
· Experience in internal auditing as well as working with regulatory agencies
· 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
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.