QA Auditor

Description:

This position provides quality oversight to the material quality system at Birmingham Laboratories. This includes establishing the material management compliance strategy and the supplier audit strategy at the plant site, including execution of both internal and external audits. All company safety, health and environmental policies, procedures and directives will be adhered to while performing assigned tasks.Oversight of technical & compliance aspects of Auditing (Internal and external programs)Responsible for establishing and maintaining the Supplier Management programResponsible for management of the internal audit programWork independentlyEfficient time management and able to manage multiple projects concurrently as the responsible party for Quality System aspects of Material Management and Supplier/Vendor management.Routinely represents Evonik directly with external suppliers as part of the Quality System ownershipWork constructively with management to further elaborate and implement a strategic vision for the operation.Works within the team structure to establish site and Business Line networks related to auditing and vendor management.Collaborate with other NC-HC sites to efficiently utilize site resources to accomplish external supplier/vendor audits.May require the scheduling & sharing of BL resources to carry out the required compliance audits.Proactively searches literature and regulatory guidance (ICH, FDA) to maintain awareness of current regulationsBuilds strong relationships with suppliers.​Operational ExcellenceDevelopment and maintenance of metrics to monitor effectiveness and compliance of internal & external audit programs.Responsible for Internal Audit Schedule – establishment and execution of the audit.Responsible for the material management strategy for the plant siteClassifies raw materials to the appropriate risk category so the material is managed appropriately at the siteCompletes supplier audits as requiredKey contact for material management discussions with customers and regulatory inspectorsLeads activities related to resolving major supplier and raw material issues at the plant site.Review and approve material related deviationsReview and approve material related change controlsApplies appropriate regulatory guidance by considering development stages as well as internal and client requirements to ensure the successful management of Supplier/Vendor ProgramProactively seek feedback from the customer (internal and external) regarding the quality and timeliness of servicesPerform other duties as may be required by manager/supervisor.Communication:Effectively communicate across all levels both internally and externally, both written and oralRespectfully responds and discusses complex and difficult topics without being defensiveAuthor, review and approve internal and external audit reports, evaluations and summaries. primary author or reviewer/approver for reports and summaries for projects of appropriate scope and complexityQualityEach individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, Quality) of the products manufactured at Evonik Birmingham Laboratories. This includes but is not limited to the following:Adherence to all written instructions.Timely reporting of all deviations to supervision.Training on each activity is completed and current and that each employee understands their assigned duties.Strict documentation practices are followed to ensure that all steps of the operation are appropriately documented.Ensure to maintain the work area in a state of cleanliness and sanitation through good housekeeping practices and applying good personal health practices.Ensure the security and safety of the product through the reporting of any potential risk to supervision immediately.Ensure the safety of the personnel and product by wearing proper PPE (Personal Protective Equipment) according to the operation being executed.Each individual should report any action that they believe could impact the SISPQ of any product immediately to supervision.​Environmental, Safety, Health, and Security (ESHS):Adhere to ESHS programs, rules, and proceduresAssume personal accountability for individual behaviors related to ESHS activitiesHave appropriate knowledge and tools prior to performing a task.Complete all required ESHS training and remain current with applicable learning plans.Report all injuries within the same shift of the incident occurring.Inform direct supervision of any ESHS hazards or concerns in the workplace.Provide feedback and coaching to coworkers on both safe and unsafe behaviors and conditions.Actively participate in the ESHS management system as directed by supervision.Additional responsibilities may be assigned based on the needs of the site.STRATEGIC FOCUS: (The focus desired and expected on the position over the next 1-3 years)This position is responsible for establishing a sustainable, compliant Supplier and Vendor Management Program at Birmingham Laboratories. This individual is responsible for continued compliance of the Auditor and Supplier and Material management programs at the site. This includes continuously improving the programs to ensure they meet cGMP requirements and are efficiently executed at the site.

Skills:

Audit, Internal audit, Materials management, Supplier quality, vendor management, cgmp

Top Skills Details:

Audit,Internal audit,Materials management,Supplier quality,vendor management,cgmp

Additional Skills & Qualifications:

Minimum 5 years quality experience in the pharmaceutical or medical device industry preferred.Minimum 2 years’ experience auditing (Required)Minimum 1 year in a supplier quality role (Required)BS in chemistry, biological sciences, engineering, science, or equivalent experience.Knowledge of cGMP requirements and experience in the application and interpretation of cGMP requirements.Experience with the following regulations and ISO standards: 21 CFR Part 210/211, 21CFR Part 820, and ISO 13485.Lead auditor training preferred - (ISO 13485, EU MDR, MDSAP, or equivalent)Must be able to work independently and to establish a working network to assure compliance of the Material Quality System.Knowledge of and experience in cleanroom operations is preferred.Very knowledgeable with respect the compliance requirements associated with material management.Able to apply compliance standards to daily production situations.Good communication skills.Ability to work in an undefined environment.Must provide 24/7 coverage for areas supported, willing to work nights and weekends as needed.Must be able to support up to 50% travel to vendor locations.

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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