Batch Auditor Technician

Description

Candidates must be available to work any shift/weekend based on business needs

Trainings will Monday to Friday be on 1st shift 8-4PM until certifications completion and after that will go to assigned shift

Daily Work Schedule Expectations Shift 10-6PM – Tuesday to Saturday

Batch Auditor Technician I

Purpose :

• The Audit Technician reviews the batch records data from production areas to ensure the documentation complies with the Good Manufacturing Practices (cGMPs), documentation practices and applicable regulations.
• Maintain custody of batch records and supporting data audited in the document control area. Facilitate batch record documentation during internal and external inspections.
• The Audit Technician is responsible for the approval and release of manufactured/packaged products.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Review and audit the batch records for production areas. The audit process includes checking material consumption, environmental conditions, evaluation of critical parameters, cleaning, printed material usage, expiration dates.
• The review and audit may be conducted at the production areas on-line based according to business needs.
• Identify and address timely correction of discrepancies observed during the batch record review following cGMPs and documentation practices. The auditor is responsible for evaluating the discrepancies and to contact the SME for resolution.
• Evaluate and approve the exceptions generated during the manufacturing and/or packaging process.
• Also, responsible for obtaining the supporting data to approve and close Hold documents.
• Provide final disposition of drug products, components, raw materials, and finish products as applicable.
• Create or verify certificates of analysis, compliance or manufacture for products as required.
• Keep manual or electronic tracking of documents processed and those pending review.
• Be the custodian for documents in a controlled area and facilitate internal or external requests. Prepare applicable documentation packages for record retention.
• Has the knowledge and utilize electronic systems to review inventory transactions and provide disposition (e.g. SAP), exception documents (e.g. Soltraqs), and electronic manufacturing batch records (e.g. POMsNet) among others.
• Generate and provide reports to area supervisor or management upon request. File batch record documentation after receiving and/or approval and generate the associated documentation of this process.
• Responsible for performing tasks assigned based on identified business area needs.
• May be required to perform quality control inspections, verifications and documentation review for manufacturing or finishing areas as required.

Qualifications :

List required and preferred qualifications up to 10). Include education, skills and experience.

• Associate Degree – Science or Business Administration
• 4 years minimum experience in Quality Control in a pharma related industry. 3 year experience in batch records audit (preferred)
• Knowledge of GMPs, DEA controlled substances handling (preferred)
• Able to perform basic math operations and to handle documentation using electronic systems
• Good verbal and written communication skills (English and Spanish)

Are you open to look at candidates willing to relocate at their own expense? NO

What are the top 3-5 skills, experience or education required for this position?

• Associate degree – Science or Business Administration
• Experience in Batch Record Review or Quality Control in a Pharma related industry.
• Knowledge of GMPs, DEA controlled substances handling (preferred)
• Able to perform basic math operations and to handle documentation using electronic systems
• Good verbal and written communication skills

What is a nice to have (but not required) skill, experience, education, or certification? n/a

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ? Open Office/ Team environment

Candidates must be available to work any shift/weekend based on business needs

Trainings will Monday to Friday be on 1st shift 8-4PM until certifications completion and after that will go to assigned shift

Is overtime offered or required? Yes

Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? Onsite

If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? Onsite

Is Travel expected? If so, will it primarily be domestic or international? NO

Is the new hire going to be working with Toxins? NO

Experience Level = 1-3 Years