Documentation Specialist

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.

Job Description

• 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.
• May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements.
• Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols. Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
• The individual tracks/reports metrics as needed. May provide training/ presentations as needed.
• May help with regulatory inspections.

Education Minimum Requirement:

Bachelor’s degree in science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.

Required Experience and Skills:

Previous Experience in the pharmaceutical industry.

Preferred Experience and 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.
• Additional: Beta Lactam screening required for this role.