QA Specialist

Evonik•Birmingham, AL

1d•Hybrid

About The Position

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. Click on the link below to learn what our employees have to say about Evonik: https://careers.evonik.com/en/about/meet-the-team/ 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.

Requirements

Bachelor of Science degree in Chemistry, Biology, engineering or related field preferred.
NOTE: Relevant work experience may be substituted for a degree.
3-5 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

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.