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Specialist Product Quality
Advanced Bio-Logic Solutions Corp Thousand Oaks , CA 91360
Posted 1 week ago
Description:Note:
- 3 year contract
- 100% remote
- Shift/Schedule: 8:00 -4:30 pm (flex) -Monday - Friday
- Candidates must have GMP and pharmaceutical experience
- Let’s do this! Let’s change the world! In this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
- The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections.
- Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations.
- Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.
- Build and maintain technical GMP documents and product stability studies
- Review, verify, report, and archive GMP data for clinical and commercial products
- Apply keen attention to detail to conduct data review and reports
- Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
- Adeptly manage time-sensitive activities independently
- Win
- What we expect of you
- We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an expert with these qualifications.
- Doctorate degree
- Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience,
- Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
- Associate’s degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience
- High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience
- Bachelor's degree or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
- Experience working in a regulated environment (either direct GMP or technical support)
- Previous experience with either synthetic or biologic stability program management (e.g., designing studies, authoring stability study documents, reviewing data monthly and annually, coordinating with Supply Chain/Manufacturing groups to obtain samples, collaboration with Quality Control testing groups, etc.,).
- Strong project management skills
- Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
- General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
- Experience using computer software such as MS Office (i.e., Excel, Word, Project), LIMS, document management systems, regulatory application systems, etc.
- Experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
- 2
- Org Unit
- Stability Program Management
- Job Site
- Remote Worker
- Job Posting Service Type
- Temp
- QA Sr. Associate will be responsible for Quality On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews, real-time decision-making regarding quality requirements.
- Stability Study Design
- Data Analysis
- Technical Writing
- GMP or previous pharmaceutical experience
- Must have a degree; science background is preferred
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