QA Batch Record Review I

Nature and Scope

This position is responsible for providing the Quality Assurance review associated with the manufacture of safe pure effective and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs) policies and current Good Manufacturing Procedures. The Batch Record reviewer ensures all documentation processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. This position requires effective collaboration with other departments on production issues / situations product dispositions and investigations. The Batch Record reviewer works under the direct supervision of the QA Supervisor.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

Execute timely reviews all batch documentation for accuracy and completeness according to cGMPs.

Execute batch record review and review of supporting systems including Veeva Vault and Trackwise.

Adheres to internal and external guidelines specifications and regulatory requirements while reviewing batch documentation.

Ensures all work in performed and documented in accordance with existing company policies and procedures as well as cGMP and health and safety requirements.

Work with area personnel to resolve errors and / or discrepancies.

Assures all errors and corrections are resolved according to SOP requirements.

Enter data into applicable spreadsheets / databases.

Update metric reporting as needed.

Submit error free batch records to release for product shipments.

Execute batch record review of Media Fills and Research and Development (R&D) batches.

Review and approve preliminary batch records after batch record assembly.

Review logbooks for accuracy after creation.

At any time may be required to perform the job responsibilities for the Documentation Specialist.

Perform any other tasks / duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and / or ability required.

High School Diploma or GED equivalent required. Associates or Degree preferred.

Minimum 3 years experience preferred in QA in a cGMP manufacturing environment.

Experience in QA Compliance Auditing in a cGMP manufacturing environment is preferred.

Demonstrated success in managing multiple activities at the same time and producing outstanding results.

Skills in Microsoft Word and Excel are required.

Excellent organizational interpersonal and communication skills (written and oral) required.

Strong attention to detail and adherence to Standard Operating Procedures (SOPs).

Ability to take feedback constructively and function in a team-oriented work environment.

Ability to work overtime as needed.

Physical Environment and Requirements

Employee must be able to occasionally lift and / or move up to 25 pounds.

Expected Hourly Rate :

$21.06 - $24.00

The hourly rate displayed is the hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications education knowledge skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare life insurance profit sharing paid time off matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

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Our recruiting process includes multiple in person and / or video interviews and assessments.

If you are unsure about the legitimacy of a message contact John Rossini at before responding.

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Key Skills

Bakery & Pastry,Computer Software,Jira,Accident Investigation,Chemistry

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 21 - 24