A brief overview
The Quality Control Process Manager will assist with the continuous development, maintenance, and oversight of QC general processes and IT Systems like LIMS, LES, CDS, ERP at Bachem U.S. sites. This position will collaborate with other team members and departments at sites in the U.S. and Europe to implement different aspects of the previously mentioned systems but also not limited to other topics and projects (i.e. other electronic workflows and systems, eForms or modules). This position will also assist with the maintenance, user training and system administration of the QC IT systems at the U.S. sites. The Quality Control Process Manager will assist with developing metrics, KPIs and issuing reports. This position will also assist QC leadership with implementing optimization of current global QC processes (e.g. for release activities, references, etc.).
What you will do
- Manage electronic master data in QC IT systems and actively support the teams with setting up master data
- Handle quality events and validation activities for QC IT Systems, and writing of documents such as SOPs
- Supporting QC leadership with the implementing of new or revised general QC processes including but not limited to QC IT Systems, release processes, reference processes
- Develop metrics for support of management and various reports
- Assist with implementation of different modules of QC IT Systems software at Bachem
- Assist with design and implementation of different features of new modules of QC IT systems currently employed (new modules, new workflows, upgrades, etc.)
- Training of other departments in QC IT Systems and creation of training documentation
Qualifications
- Bachelor's degree in a science related field – chemistry, biology or equivalent
- Minimum of 3 years of experience in Quality Control
- Experience in cGMP manufacturing
- Experience in writing standard operating procedures, specifications, and technical reports
- Experience with electronic Systems related to Quality Control (LIMS, CDS, etc.)
- Experience in developing metrics
- Technical writing experience
- General hands-on experience with electronic system configuration and implementation (preferred)
- Comprehensive knowledge of electronic quality system management software (Trackwise, MasterControl, etc.)
- Communicate effectively and ability to function well in a team environment
- 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
- Ability to interact well with co-workers, customers, regulatory agency auditors and senior management
- Excellent written and oral communication skills
- Technically savvy
- Six Sigma Green Belt Certification (preferred)
- Lean Six Sigma Black Belt (preferred)
Base Salary Range: $82,560 - $113,520
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Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards
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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.
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Corporate Social Responsibility
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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.
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Bachem Americas is an Equal Opportunity Employer
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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
