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Basic knowledge of regulatory compliance of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. The External Manufacturing Specialist coordinates all aspects of contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Overview of this Position:The Compliance Specialist II supports and upholds the quality management system to ensure the consistent manufacture and testing of cGMP compliant drug products. These duties include providing oversight and general support of the compliance processes including, but not limited to, conducting supplier audits, authoring annual product review reports, conducting internal audits, supporting client audits, supporting external regulatory audits (e.g. FDA, EU), writing effective audit reports, following up on audit responses and commitments (both internal and external), and oversight and enforcement of GMP regulations.
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This will include supporting the technical transfer process assessments, Pilot Plant activities and transfer into cGMP manufacturing. Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
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Good knowledge of FDA and EMA regulations, ICH and cGMP guidelines. Represent WuXi Bio as SME for QA for regulatory inspections and client audits. Bachelor, Master or PhD degree Biochemistry or other related science discipline.
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Additional Considerations: The incumbent must be skilled in data integrity, manufacturing and laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures. The Validation Engineer III must have thorough knowledge and experience with global regulatory requirements for Validation, including ERES (Part 11 and Annex 11) and current GAMP5 guidelines.
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Working knowledge of applicable Regulatory requirements (cGMP, DEA, OSHA, BOCA, EPA) and contract law. Expertise in tech transfer, GMPs, facility fit, cell biology, cell culture technology, protein purification, protein chemistry and/or bioengineering.
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Regulatory & compliance understand the relevant cGMP regulations and PCH quality standards that apply to our product portfolio of OTC monograph, NDA, Dietary supplement, and medical device products translate these in practical ways in evaluation of potential suppliers.
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In a highly regulated industry (medical devices or pharmaceutical strongly preferred)Strong medical device experience proficient with FDA QSR/cGMP and ISO13485 requirements to maintain commitment to environmental and quality regulationsExperience with Sustaining of released productsUS work authorization is a precondition of employment.
$120,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Certifications in cGMP and familiarity with regulatory norms are preferred. Benefits of the Sr Supplier Quality Specialist (cGMP) : Excellent opportunity for career advancement. We are seeking a qualified Sr Supplier Quality Specialist (cGMP) to work onsite for an opportunity paying up to $95K annually, based on experience, which is located in the area of Jackson, Wisconsin.
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Strong knowledge of regulatory requirements and guidelines (e.g., cGMP, GLP, ICH) governing pharmaceutical manufacturing and testing. This role involves various activities related to quality assurance, quality control, and compliance with regulatory standards to ensure the safety, efficacy, and integrity of pharmaceutical products.
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Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Part brand ambassador, part clinical technician. Employee assistance program (EAP.
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Conduct basic screening procedures (e.g. reviewing health related documents, taking vital signs and performing finger sticks) There are so many ways Octapharma Plasma can enhance your life and your career.
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Significant experience in cGMP pharmaceutical setting preferably oral solid dosage. Provide insight and direction to changes in regulatory and industry standards for equipment qualification, data integrity, and validation.
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SUMMARY:The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
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As the job market remains highly competitive, we have seen a surge in "rage applying." This is when candidates apply to multiple jobs, often without considering whether they are truly interested in the role. Rage applying goes hand-in-hand with quiet quitting. Often, employees want to entertain the thoughts and feelings of leaving their job, but they aren't necessarily serious about leaving yet. Meanwhile, other employees engaging in this trend are actually trying to find a better role. As a recruiter, it can be hard to identify who are the real applicants in a sea full of quiet quitters, but understanding rage applying and identifying red flags will certainly help.
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Building a Candidate Pipeline Through Internships
Building a candidate pipeline through a great internship program for local college students and recent graduates at local universities is a great and cost-effective way to attract and retain top talent. By offering meaningful and impactful work experiences, regular feedback, coaching, and mentorship, you can create a positive internship experience that will make your organization a sought-after destination for future employees. This not only benefits the organization in the short-term but also in the long-term, as you'll have a pool of well-trained and experienced candidates who may be interested in full-time employment once they graduate. Furthermore, building relationships with local universities and college students can increase brand awareness and build a positive reputation for your organization in the local community.