Search Jobs
Quality Specialist - I (Assistant)
770 Sumneytown Pike Lansdale, PA 19446 US
Job Description
Target Pay Rate: 30-39.92/hr **salary will be commensurate with experience
Job Description:
The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team).
With guidance from the Batch Record Review Quality Manager, the Quality Specialist ensures quality, and compliance of products manufactured by the functional area and adherence to Good Manufacturing and Documentation Practices.
Primary Activities:
• Fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs) and competency-based activities
• Learns cGMPs, the manufacturing process, and our company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms
• Provides presence on the shop floor to support compliance and data integrity.
• Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors
• Reviews and approves new and updated SOPs and Controlled Job Aids
• Actively participates in the Tier process and uses this forum to make concerns visible and to partner with the functional area on resolution
• Fosters a customer service attitude within the functional area
Qualifications:
Required Education: • Bachelor's degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience. Required Experience and Skills: • Minimum 1-2 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting. • Evidence of good oral and written communication skills. • Familiarity with GMP documentation review • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment. Preferred Experience and Skills: • Experience in quality systems, authoring and approving GMP documents. • Experience with Aseptic gowning may be required. • Demonstrated analytical aptitude, critical thinking skills and problem-solving skills. • Titers may be required.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Lansdale, PA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.