Production Document Support/Quality Specialist

Employer
Bachem
Location
Torrance, CA, US
Posted
Oct 16, 2020
Ref
615308801
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Production Document Support/Quality Specialist will support Production Department and author, edit, review, evaluate and maintain Production documents such as BPR, SOP, Protocol, Report, etc. to verify accuracy before final presentation. The Specialist will ensure good documentation pratice (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.
  • Thorough understanding of all peptide manufacturing stages and various in-process analytical methods.
  • Efficient and effective to get the job done in timely manner.
  • Independent, self-motivated, and Multi-tasking.
  • Accurate and detail oriented.
  • GMP mindset with a high degree of self-discipline.
  • Ability to perform under time pressure and adhere to guidelines and timelines.
  • Excellent communication and interpersonal skills.
  • Dedicated, loyal and hardworking.


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 in managing documents in a cGMP environment, particularly in API manufacturing is 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


Nearest Major Market: Los Angeles