GMP/ FDA Technician

Bachelors Degree, A minimum of 2 years of GMP experience, Pharmaceutical/ Medical Device/ OTC Drug/ Cosmetic and/or Food and Dietary Supplements Production, Basic working knowledge of cGMP requirements, FDA enforcement issues
Contract W2, 12 Months
Depends on Experience
Travel required to 10%.

Job Description

Please note that this is a 1 year contract position. 

- Schedule is flexible, but could be M-F 730am-400pm
- Train for 2-3 weeks


Bachelor's degree required
- At least 2 years of experience
- Must be well organized and very detailed
- Will be reviewing Batch Records and reviewing complaints
- Will be creating certificates for foreign affiliates
- Will interact with manufacturing shop floor and/or plant workers
- Must have GMP experience/knowledge
- Must have excellent communication skills
- Will also help file paperwork

Position Overview
Support batch record release team by reviewing/compiling batch record documentation, generating certificates for foreign affiliates and completing batch record review for complaints. All tasks will be completed with the good manufacturing and documentation practices as established in the code of local government regulations and company procedures.

Key Responsibilities
Perform quality review of production records including manufacturing, packaging, and laboratory documents.
Responsible for quality releases of finished product based on conformance to established standards
Review compliance records, specifications, procedures and other documents, as required.
Assists in document preparation for regulatory agency visits and Corporate/internal audits.
Prepare and send certificates of analysis for foreign affiliates.
Review batch records for complaint investigations.
Conduct walkthroughs and assessments of GMP areas.
Partner with Operations for issue resolution.
File completed batch records appropriately.
Apply quality assurance processes, procedures, and activities.
Documentation is clear and grammatically correct in accordance with GMP and site procedures.
Under direction from management, participate in continuous improvement projects.
Report improvements to management.
Other tasks as determined by management.
Ensure quality and compliance in all my actions by:
All employees
a. Attend GMP training on the schedule designated for my role and as appropriate for my role.
b. Adhere to strict compliance with procedures applicable to my role.
c. Exercise the highest level of integrity in the tasks that I perform.
d. In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
e. Embrace a behavior of employee involvement and commitment to doing the job right the first time.

ESSENTIAL FUNCTIONS: Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME
Support batch record release team by reviewing/compiling supporting documentation and preparation of foreign affiliates certificates of analysis. 50%
Conduct area walkthroughs and assessments as well as provide real-time support to Product Manufacturing and Packaging. 30%
Review batch records for complaint investigations. 20%

Qualifications
Education:
• BA/BS

Experience:
• A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.

Knowledge, Skills and Abilities:
• Basic working knowledge of cGMP requirements and current FDA enforcement issues.
• Ability to communicate thoughts and ideas effectively – verbal and written.
• Demonstrated ability to accomplish work goals.
• Effectively work within a team environment.

Applicants must provide their phone number. Reference job number A1968. 

Dice Id : NETSO
Position Id : A1968
Originally Posted : 2 weeks ago
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