Quality Specialist - I (Assistant)
Full time
at Innova Solutions
in
Online
Posted on April 9, 2024
Job details
Innova Solutions is immediately hiring for a Quality Specialist. Position : Type: Full Time, Contract Duration : 09+ Months Location: Lansdale, Pennsylvania 19446 As a Quality Specialist, your responsibilities::
- This candidate provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
- With guidance from the IPT Quality Leadership team, the employee ensures product / process quality and performs activities to facilitate the release of product to the marketplace.
- The candidate performs 100% process document review for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time.
- Specific responsibilities include but are not limited to the following: Performs 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E).
- Maintains any tracking databases and logs associated with this review.
- Coordinates with Production to discuss, resolve, and eliminate documentation observations.
- Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
- Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
- Prioritizes review of process documents in order to maximize cycle-time efficiency.
- Performs SAP transactions required to document Batch Record review.
- Bachelor's degree/master's degree.
- Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
- Minimum 1 year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
- Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Attention to detail, flexibility and an awareness of production and attendant quality control problems.
- Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Preferred Experience and Skills:
- Familiarity with vaccine and/or pharmaceutical processing.
- Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
- Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial.
- Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.
- Quality operations background.
- Batch record review experience.
- Documentation experience
- SAP/LIMS/ electronic batch records (EBR)
- Self sufficient
- Adaptable
- Collaborative
- Team Player *Note*: -Hybrid role (1-2 days/week remote option only when contractor is fully trained).
- Flexible schedule. Not interested in candidates with short term assignments on their resumes.
- Looking for GMP/PHARMA/BIO-PHARMA profiles with batch record documentation experience.
- *Not looking sample testing/chemist/biologist/microbiologist profiles*. Possibility of extension.
- One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated® Client Diamond Award Winner (2020)
- One of the Largest Certified MBE Companies in the NMSDC Network (2022)
- Advanced Tier Services partner with AWS and Gold with MS
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