QA Specialist

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

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This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality management System documentation. This position will be required to review manufacturing batch production records and supporting QC data. This position may be required to review and approve validation documentation, prior to and after execution. All company safety, health and environmental policies, procedures and directives will be adhered to while performing assigned tasks.

RESPONSIBILITIES

Routine Quality Assurance functions, to include but not limited to :

Operations Support

Perform room clearance prior to and during manufacturing Review campaigns of for PDS documentation Products, and final PDS Services, disposition and of raw material and fill / finish component.

Review room cleaning logs.

Review data to support the testing of site utilities (e.g. WFI, steam, nitrogen, etc.).

Review data support the environmental monitoring of cleanrooms.

Review and disposition of all manufacturing and packaging batch tickets.

Review and approve documents within the change control system.

Provide on-the-floor support during manufacturing campaigns for PDS Products, PDS Services and MDS.

Provide on-call support during manufacturing campaigns for PDS Products, PDS Services and MDS.

Additional task may be assigned based on experience and business need.

Lead product quality and System improvements activities.

Gather and analyze data to identify opportunities for quality improvement.

REQUIREMENTS

Bachelor of Science degree in Chemistry, Biology, engineering or related field preferred.

NOTE : Relevant work experience may be substituted for a degree.

2-5 years' experience in pharmaceutical or medical device manufacturing.

Minimum 1 year experience in a pharmaceutical or medical device Quality Assurance role

Proficient computer skills, Microsoft Word, Excel, Access

High attention to detail, organization, and accuracy

Strong written and verbal communication skills

Good interpersonal skills

Knowledge of FDA's cGMP and / or QSR quality system requirements

Comprehensive technical skills / knowledge

Applied statistics experience

Validation experience, including process validation

Advanced analytical and problem solving skills

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.