Quality Assurance Specialist

4 days ago

Miamisburg, United States Dexian Full time

Job Description:

Job Title: Quality Assurance Expert

Location: Miamisburg OH 45342, Onsite

Duration: 04+ month contract (Extendable).

Hourly Pay: $20/hr to $27/hr on W2 without benefits on W2

Schedule: Mon - Fri, Business hours


Job Description:

Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site’s maintenance, development, and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all aspects of the GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site compliance activities through regulatory recordkeeping and reporting.


ESSENTIAL JOB FUNCTIONS

• Process Improvement

• Actively participate in the development, implementation, and improvement of Quality Systems.

• Routinely support and recommend ongoing process improvements within the department, ensuring efficient and value-added processes.

• Lead and participate in work with Production, QC, Procurement, Packaging, Maintenance, Customer Service, and Marketing to resolve issues and failures with site products and equipment. Work closely with the site departments to implement process changes based on the investigation conclusion.

• Oversee the Trackwise system and aid when necessary to end users to ensure appropriate entries are made and resolution is achieved in a timely manner.

• When necessary present various quality system training topics to site personnel.

• Identify opportunities for process improvement.

• Ensure acceptable product and process consistency

• Serve as a primary reviewer of executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release.

• Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.

• Assist in writing, reviewing, or approving GMP Operating Procedures, Validation

Protocols/Reports, Master Production Records, Specifications, and other documents for GMP products.

• Supports the site Compliance activities.

• Ensure reports are complete and accurate for HR4You, Trackwise, and Mango and site quality metrics.

• Ensure appropriate site Quality Assurance personnel are trained as a backup for the system’s role.

• Facilitate training of other site personnel as required.

• Follow all safety and quality requirements to complete assigned work.

Job Description:

• Remains up to date on regulatory requirements, as well as company and corporate quality policies through means such as intercompany meetings, webinars, email services, etc.

• Maintain, clean, and keep safe all work areas and equipment.

• Maintain personal protective equipment.

• Complete the volume of work required to meet departmental goals and meet deadlines.

• Immediately report any situation that could compromise safety or quality.

• Exemplary attendance and adherence to schedule.

• Communicate the status of operations and bring critical deviations to the attention of Quality

Manager or Site Director in the absence of the Quality Manager.

• Provide complete and accurate records consistent with quality guidelines.

• Develop and promote cross-functional partnerships with other departments.

• Ability to serve on committees to improve department, site, or company performance.

• Committees may focus on safety, quality, inventory, output, costs, etc.

• In compliance with change control procedures, improve processes through the application of industry knowledge, experience, and principles.

• Miscellaneous duties and tasks as assigned by the Quality Manager.


BASIC QUALIFICATIONS

Education and Experience:

• Bachelor’s degree in chemistry, Biology, or other Life Science required with 2 or more years GMP GMP-related.

• Experience in the chemical, specialty chemical, and/or pharmaceutical industry.

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