Work Location : Miamisburg, Ohio
Shift :
Department : LS-SC-PEMQ Quality Control
Hiring Manager : Melissa Leonard
This information is for internals only. Please do not share outside of the organization.
Your Role
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 GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site's compliance activities through regulatory recordkeeping and reporting. Specific job duties include :
Actively participate in the development, implementation, and improvement of Quality Systems.
Routinely support and recommend ongoing process improvements within 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 investigation conclusion.Oversee 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 consistencyServe 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's Compliance activitiesEnsure reports are complete and accurate for HR4You, Trackwise, and Mango and site quality metrics.Ensure appropriate site Quality Assurance personnel are trained as backup for systems role.Facilitate training of other site personnel as required.Follow all safety and quality requirements to complete assigned work.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 application of industry knowledge, experience, and principles.Miscellaneous duties and tasks as assigned by Quality Manager.Who You Are
Minimum Qualifications :
Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline2 years of experience in an independent lab within a manufacturing or research environmentPreferred Qualifications :
Experience in high volume and high data environmentknowledge of chemistry with an emphasis on analytical or organic chemistryWorking knowledge of cGMP, cGLP, cGDP, and ISO 9001 proceduresKnowledge of ISO and GMP quality standardsProficient in Microsoft Office SuiteThe Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.