Documentation Specialist
: Job Details :

Responsibilities:

• The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
• The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
• May perform quarantine functions and accountability reviews.
• Supports special projects as assigned.
• The role follows cGMP and routinely makes decisions using cGMP/process knowledge.

Qualifications:

• Education Minimum Requirement: Bachelor's degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.

Required Skills:

• Previous Experience in the pharmaceutical industry.

Preferred Skills:

• Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role.
• Previous experience in food or pharmaceutical environment in regulatory/inspection role.
• Previous experience in project management, process data analysis.
• Lean Six Sigma Certification
• Previous Experience with SAP,MEDS, etc.

Shift Requirements:

• This will be a rotating shift role with the following hours: 6:30a-3:30p and 1:30p-10:30p. The successful candidate will support aseptic operations on rotating shift.