Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
You already suscribed to this job alert.
No Thanks
US
What job do you want?

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply Now
Quality Assurance Associate at Synerfac

Quality Assurance Associate

Synerfac Pennsville, NJ Full-Time
Apply Now

Create Job Alert.

Get similar jobs sent to your email

QA Specialist

Sr. QA Specialist

Our client located in Southern, NJ is currently looking to fill a QA Specialist role. This company works with many pharmaceutical companies around the world and offers its expertise in development and manufacturing. Headquartered overseas the company's US Corporate office is located right here in Southern, NJ. Please review the duties and description below and if you fill you have the experience our client is looking for please submit your resume for review.

SUMMARY:

The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.

ESSENTIAL DUTIES, RESPONSIBILITIES:

*Reviews, approve and tracks executed production records.
*Reviews and approves production investigations.
*Reviews lab sample results and manufacturing records relative to qualification/validation activities.
*Conducts, write, and reviews quality related investigations as appropriate.
*Reviews and approves Master Production Records.
*Responsible for cGMP compliance of assigned manufacturing operations / areas.
*Completes pre-campaign action items as assigned.
*Is responsible for the conditional / final release of materials.
*Reviews finished product labels.
*Reviews and approves COAs.
*Prepares and reviews product trees.
*Writes and reviews Product Validation / Qualification / Assessments documents.
*Writes and reviews Equipment Qualifications / Assessments documents.
*Writes and reviews Computerized Systems Validations / Assessments documents.
*Reviews, evaluate and approves minor equipment changes.
*Conducts GMP inspections.
*Conducts environmental monitoring.
*Reviews and approves DMFs as appropriate.
*Maintains QA databases for products / equipment as appropriate.

*Adheres to all applicable SHE and CGMP regulations.

EDUCATION AND EXPERIENCE:

*A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience. A BA/BS degree in microbiology is preferred.

*Thorough knowledge of cGMP is required.

EDUCATION AND EXPERIENCE:

*A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience. A BA/BS degree in microbiology is preferred.

*Thorough knowledge of cGMP is required.

Recommended skills

Certified Global Meeting Planner
Good Manufacturing Practices
Pharmaceutical Manufacturing
Manufacturing
Chemistry
Biology
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve Careerbuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 75413

Careerbuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using Careerbuilder you are agreeing to comply with and be subject to the Careerbuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.