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Production Document Support, Quality

Employer
Bachem
Location
Torrance, CA
Start date
Aug 14, 2022

View more

Discipline
Manufacturing & Production, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

Responsibilities

The Production Document Support/Quality will support Production Department, and author, edit, review, evaluate, and maintain Production documents, such as BPR, SOP, Protocol, Report, and etc., to verify accuracy before 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.

Your Tasks

  • Author, edit, review, evaluate, and maintain cGMP documentation
  • Ensure efficient collaboration between Production department and other supporting departments such as Operations, Logistics, QC, and QA
  • Verify that written procedures (SOP, BPR) and cGMP guidelines are followed
  • Support the Production team with the necessary resources to ensure efficient and safe manufacturing operations
  • Comply with SOP’s, BPR’s and cGMP in all aspects of the work performed.
  • Write technical reports and summaries
  • Adhere to manufacturing schedules and timelines
  • Propose technical and chemical improvements of the manufacturing process

Your Profile

  • Bachelor or Master’s Degree in Organic Chemistry, Biochemistry or the equivalent.
  • 2 – 3 years’ hands-on experience in a chemistry laboratory either in academia or in industry
  • Experience of managing documents in a cGMP environment, particularly in API manufacturing. Highly desirable
  • Extensive knowledge of solvent, waste and materials flow
  • Knowledge of the chemical compositions, structures, and properties of substances knowledge of the chemical processes and transformations, including uses of chemicals, their interactions, danger signs, production techniques, and disposal methods
  • Working experience with mandatory safety, health and compliance regulations as specified by federal, state, and local governments
  • Ability to work late shifts on a continuous basis
  • Capable of working methodically and accordingly adhering to rules and regulations
  • Entering or recording information in written or electronic form
  • Strong knowledge and command of the English language; excellent written and oral skills
  • Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of compositions, and grammar

Preferred

  • Experience with Master Control and SAP
  • Industry experience
  • Understanding of GMP according to ICH Q7

Company

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.

Stock Symbol: BANB

Stock Exchange: SWX Swiss Exchange

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Find Us
Website
Phone
(888) 422-2436
Location
3132 Kashiwa Street
Torrance
California
90505
United States
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