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Quality Specialist - I (Assistant)
2778 South East Side Highway Elkton, VA 22827 US
Job Description
Target Pay Rate: 30-39.92/hr **salary will be commensurate with experience
Job Description:
The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
May perform quarantine functions and accountability reviews.
Supports special projects as assigned.
The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
May work with customers to resolve problems and to satisfy quality and production needs.
Follows site safety requirements.
Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
The individual tracks/reports metrics as needed.
May provide training/ presentations as needed.
May help with regulatory inspections.
Qualifications:
Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/inspection role. Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP,MEDS, etc. Additional: Beta Lactam screening required for this role. Shift Requirements: 8am-5pm. The successful candidate will support aseptic operations.
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.
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