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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.
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.
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.
Qualifications : 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.
Shift Requirements : 8am-5pm. The successful candidate will support aseptic operations.
Last updated : 2024-05-14
Full Time
$86k-103k (estimate)
04/25/2024
06/21/2024
innovasolutions.com
SANTA CLARA, CA
500 - 1,000
1997
Private
LINDA L MOORE
$10M - $50M
Innova provides enterprise cloud transformation, information management and operations managed services.
The job skills required for Quality specialist include Quality Assurance, Initiative, Auditing, Change Control, Presentation, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality specialist positions, which can be used as a reference in future career path planning. As a Quality specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality specialist. You can explore the career advancement for a Quality specialist below and select your interested title to get hiring information.
If you are interested in becoming a Quality Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Specialist jobs
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Step 3: View the best colleges and universities for Quality Specialist.