Quality Specialist - I (Assistant)

Company: Innova Solutions
Location: Lansdale
Posted on: April 15, 2024

Job Description:

Innova Solutions is immediately hiring for a Quality Specialist.Position : Type: Full Time, ContractDuration : 09+ MonthsLocation: 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.Qualifications:
  • 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.Required Experience and Skills:
    • 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. Key skills:
      • Quality operations background.
      • Batch record review experience.
      • Documentation experience
      • SAP/LIMS/ electronic batch records (EBR) Personality:
        • 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.Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Thank you!Rajesh chitrada
          (+1) 213 - 797 - 4291PAY RANGE AND BENEFITS: Pay Range*: Between $36.00 - $39.92 Per Hour*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions:
          • 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 MSWebsite: Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.

Keywords: Innova Solutions, Cherry Hill , Quality Specialist - I (Assistant), Other , Lansdale, New Jersey