Production Document Support Specialist

Bachem AG • Vista, CA

1d • $26 - $51

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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)

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees