Bachem Holding AG
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 overview The Production Document Support Specialist will support the production department in authoring, editing, reviewing and maintaining production documents to verify accuracy before on‑time final presentation. The specialist will ensure good documentation practice (GDP) implementation and build efficient collaboration between production department and other supporting departments such as operations, logistics, QC, and QA.
What you will do
Perform and coordinate BPR (batch record) technical reviews. Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed. Exercise independent judgment regarding cGMP document entry evaluation.
Coordinate real‑time batch record review/corrections across multiple functions, i.e., Production, QA
Attend and scribe daily huddles; coordinate collaboration between Production department and other departments such as Operations, Logistics, QC, and QA; perform other tasks supporting Production as assigned
Perform controlled print tasks for time‑sensitive production operations
Comply with SOP’s, BPR’s and cGMP in all aspects of the work performed.
Participate in internal audits, support GMP readiness activities, audits and inspections
Implement improvements in quality systems and SOPs. Manage operational excellence tasks.
Process assigned tasks and reviews within tight timelines
Qualifications
Bachelor's degree in science, engineering, or related discipline or
Associate degree in science, engineering, or related discipline with 2+ years’ experience in cGMP setting
Experience managing documents in a cGMP environment, particularly in API manufacturing (preferred)
Knowledge of cGMP and FDA regulations (preferred)
Experience with Master Control, SAP, Excel, Word, PowerPoint (preferred)
Industry experience with peptide manufacturing (preferred)
Working experience with mandatory safety, health and compliance regulations as specified by federal, state, and local agencies (preferred)
Ability to adhere to manufacturing schedules and timelines for document support
Capable of working methodically and efficiently, while adhering to rules and regulations
Reviewing, entering or recording information in written or electronic form
Strong understanding of cGMPs, and able to comply with SOPs, BPRs and cGMP in all aspects of the work performed.
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of compositions, and grammar. Well versed in Good Documentation Practices.
Detail oriented with the ability to independently troubleshoot and resolve problems
Communicate effectively, and possess ability to function well in a team environment
Possess a GMP mindset with a high degree of self‑discipline in tasks
Ability to perform under pressure and adhere to guidelines and timelines
Excellent communication and interpersonal skills. Ability to collaborate in a proactive and solution‑focused manner, including keeping management aware of potential issues.
Ability to work in ISO7 and ISO8 controlled environments
Base Hourly Range Specialist I: $25.97 - $35.72
Specialist II: $37.00 - $50.87
Placement of new hires in these wage ranges 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 Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
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A brief overview The Production Document Support Specialist will support the production department in authoring, editing, reviewing and maintaining production documents to verify accuracy before on‑time final presentation. The specialist will ensure good documentation practice (GDP) implementation and build efficient collaboration between production department and other supporting departments such as operations, logistics, QC, and QA.
What you will do
Perform and coordinate BPR (batch record) technical reviews. Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed. Exercise independent judgment regarding cGMP document entry evaluation.
Coordinate real‑time batch record review/corrections across multiple functions, i.e., Production, QA
Attend and scribe daily huddles; coordinate collaboration between Production department and other departments such as Operations, Logistics, QC, and QA; perform other tasks supporting Production as assigned
Perform controlled print tasks for time‑sensitive production operations
Comply with SOP’s, BPR’s and cGMP in all aspects of the work performed.
Participate in internal audits, support GMP readiness activities, audits and inspections
Implement improvements in quality systems and SOPs. Manage operational excellence tasks.
Process assigned tasks and reviews within tight timelines
Qualifications
Bachelor's degree in science, engineering, or related discipline or
Associate degree in science, engineering, or related discipline with 2+ years’ experience in cGMP setting
Experience managing documents in a cGMP environment, particularly in API manufacturing (preferred)
Knowledge of cGMP and FDA regulations (preferred)
Experience with Master Control, SAP, Excel, Word, PowerPoint (preferred)
Industry experience with peptide manufacturing (preferred)
Working experience with mandatory safety, health and compliance regulations as specified by federal, state, and local agencies (preferred)
Ability to adhere to manufacturing schedules and timelines for document support
Capable of working methodically and efficiently, while adhering to rules and regulations
Reviewing, entering or recording information in written or electronic form
Strong understanding of cGMPs, and able to comply with SOPs, BPRs and cGMP in all aspects of the work performed.
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of compositions, and grammar. Well versed in Good Documentation Practices.
Detail oriented with the ability to independently troubleshoot and resolve problems
Communicate effectively, and possess ability to function well in a team environment
Possess a GMP mindset with a high degree of self‑discipline in tasks
Ability to perform under pressure and adhere to guidelines and timelines
Excellent communication and interpersonal skills. Ability to collaborate in a proactive and solution‑focused manner, including keeping management aware of potential issues.
Ability to work in ISO7 and ISO8 controlled environments
Base Hourly Range Specialist I: $25.97 - $35.72
Specialist II: $37.00 - $50.87
Placement of new hires in these wage ranges 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 Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
#J-18808-Ljbffr