Senior QA & GMP Compliance Associate
Aditi Consulting
Aditi Consulting is seeking a Sr Associate PQA in Holly Springs, North Carolina. This role requires comprehensive Quality oversight to ensure adherence to GMP standards. The ideal candidate will facilitate real-time decision-making and maintain strong partnerships between Manufacturing and Quality teams. Responsibilities include managing cGMP processes, providing guidance during testing, and supporting audit activities. Successful candidates will bring PQA/Mfg Operations experience and thrive in a collaborative environment. #J-18808-Ljbffr Aditi Consulting
- ...This role is crucial for managing samples efficiently, ensuring compliance with internal procedures, and coordinating with stakeholders... ...degree in a relevant field with at least 2 years of experience in a GMP environment. Familiarity with Labware LIMS and communication...Senior
- ...leading biopharmaceutical company in North Carolina is seeking a Senior Analyst 1 for QC Analytical Development Bioassay. This role involves executing analytical method transfers, ensuring compliance with GMP regulations, and collaborating across teams to meet project...Senior
- Collabera is seeking a Quality Control Senior Associate in Holly Springs, NC for a 12-month position. The role involves ensuring compliance with quality procedures and improving corporate... ...or related fields and have experience in GMP laboratory settings. This position also...Senior
- ...from Wednesday to Saturday. Responsibilities include ensuring compliance with procedures, improving quality management systems, and participating... ...in Chemistry or Microbiology is required, and experience in a GMP environment is preferred. Familiarity with SAP and scientific...SeniorShift work
- Initial Therapeutics, Inc. in Holly Springs, NC is seeking a Senior Manufacturing Systems Engineer specializing in automation to provide... .... The ideal candidate will possess extensive experience in GMP environments and particularly with Emerson DeltaV systems. This...Senior
- Amgen is seeking a Senior Manufacturing Systems Engineer to provide automation leadership within their Holly Springs facility.... ...will develop and maintain process control systems, ensuring compliance with GMP standards. The ideal candidate will have a degree in Engineering...Senior
- Initial Therapeutics, Inc. is seeking a Senior Manufacturing Systems Engineer in Holly Springs... ...technical leadership, enhancing the GMP Drug Substance Plant Operations through sophisticated... ...automation issues while ensuring compliance with GxP standards. Ideal candidates will...Senior
$45 - $50 per hour
A leading consulting firm is seeking a Senior Engineer for a remote role focusing on GMP Drug Substance manufacturing and tech transfer. The ideal candidate must have strong expertise in GMP processes and experience in technical problem-solving. This position requires periodic...SeniorRemote job- ...enhancing quality management systems related to microbiology and regulatory compliance, ensuring the safety of biologic products. The ideal candidate holds a BS in Chemistry or a related field, has GMP laboratory experience, and possesses knowledge of quality control...SeniorNight shiftDay shift
$109k - $204k
...& Qualification Manager to oversee capital projects, ensuring compliance and operational excellence. This role requires strong leadership... ...management skills, guiding teams through the C&Q lifecycle to support GMP operations. Candidates should have a Bachelor's degree in...SeniorRemote work- Job Title: Engineer Senior, Biotech GMP Drug Substance manufacturing, tech transfer - Remote (JP14709) Location: Holly Springs, NC. 27540... ...experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience Employee Value...SeniorRemote jobPermanent employmentContract workLocal area
- Genentech in Holly Springs, North Carolina, is hiring a Senior Principal Automation Engineer to oversee automation systems in a new manufacturing... ...organizational skills are essential, as well as knowledge of GMP and biopharmaceutical manufacturing processes. #J-18808-Ljbffr...SeniorRemote work
$94k - $174.6k
...future of medicine. The Opportunity As the QA Specialist (QA for QC), you will serve as a foundational pioneer embedding quality compliance directly into our Quality Control... ...quality compliance activities. Advanced GMP and quality regulation knowledge with experience...SeniorLocal areaRelocation- ...requires managing sample handling and documentation, ensuring compliance with internal procedures, and collaborating with internal stakeholders... ...’s degree, strong attention to detail, and experience in a GMP environment. Responsibilities include executing setup for the...Senior
- FUJIFILM Holdings America Corporation is seeking a Senior Analyst 1 in Holly Springs, NC. The role entails executing QC analytical methods, ensuring compliance with GMP regulations, and training QC lab associates. Ideal candidates should have a B.S. in Microbiology or a...Senior
- ...logistics. The ideal candidate will have a Bachelor's degree and at least 2 years of experience in quality control. Advanced understanding of GMP and laboratory practices is essential. Candidates with a Master's degree are also welcome to apply. #J-18808-Ljbffr Merck & Co.Senior
- ...manufacturing batch samples and clean utilities, as part of a 24x7 QC team. Applicants should have a strong background in QC testing, GMP regulations, and document control. The position requires good communication and documentation skills, along with a significant...Senior
- Merck & Co. is seeking a Senior Analyst 1 for Quality Control Bioassay in Holly Springs... ...analytical methods and ensuring compliance with GMP regulations. A strong understanding of... ...performing assays, reporting data, and training QC associates. #J-18808-Ljbffr Merck & Co.Senior
- ...integrity, documenting movements, and collaborating with stakeholders. A Bachelor’s degree in a scientific discipline and experience in a GMP environment are required. The position emphasizes the importance of effective communication and adaptability in a fast-paced setting....Senior
- Scorpion Therapeutics in Holly Springs is hiring a Sr Associate Quality Assurance for the night shift. This role focuses on providing... ...and new product introduction. The ideal candidate will ensure compliance with cGMP standards, oversee documentation for quality records...SeniorNight shift
$94k - $174.6k
Genentech in Holly Springs, North Carolina is looking for a QA Specialist to embed quality compliance within Quality Control operations. You will ensure that all analytical and operational data complies with the highest global regulatory standards. As a key team member,...Senior- Initial Therapeutics, Inc. is seeking a Senior Electrical Engineer to lead electrical planning and design within the Facilities & Engineering group. The role involves collaborating with capital projects teams, ensuring projects meet site standards, and delivering high-...Senior
$40 - $43 per hour
...Title: Quality Control Senior Associate Duration: 12 Months Location: Holly Springs, NC Shift:... ...night shift. Key Responsibilities Ensure compliance with procedures relating to area of... ...Operating Standard and SOP revisions. Own GMP materials relating to area of responsibility...SeniorHourly payTemporary workShift workNight shiftDay shift- Responsibilities Support the Quality oversight associated with Commissioning & Qualification (C&Q)... ...Validation (CSV). Work to be the QA partner on a varied portfolio of DTI and... ..., and issue resolution. Escalate any compliance concerns or critical gaps to QA management...Senior
- ...compendial chemistry testing. Ensure compliance with safety guidelines, cGLPs,... ..., Process Development, QA, Facilities & Engineering, Supply... ...Aseptic Manufacturing OR Associate’s + 10 years OR Bachelor’s + 8... ...resources. Preferred Qualifications GMP/pharma environment experience...SeniorFlexible hoursNight shiftDay shiftAfternoon shift
- ...ensuring the quality and compliance of initial Technology... ...ensure all GxP requirements associated with TT activities are... ...; Serves as TT SME for QA with regulators,... ...management Assists QA senior management with departmental... ...working in a GMP environment Preferred...Senior
- ...We’re Hiring! Senior Adverse Events and Compliance Specialist At Envu, we partner with our customers to design world-class, forward-thinking innovations that protect and enhance the health of environments around the world. We offer dedicated services in: Professional...SeniorPermanent employmentFull time
- SR ASSOCIATE QUALITY ASSURANCE (PQA) - NIGHT SHIFT What... ...to ensure adherence to GMP. Provide coaching/guidance... ..., quality systems, and compliance. Responsibilities... ...investigated/documented; alert senior management to quality/... ...’s +6 months in QA, manufacturing, and/or...SeniorWork at officeFlexible hoursNight shift
- ...biotech company in Holly Springs, North Carolina is seeking a Senior Manufacturing Systems Engineer to lead automation efforts... ...extensive experience in PLC systems, project management, and compliance with GMP standards. You will work closely with engineering and project...Senior
- Amgen Inc. (IR) is seeking a Senior Manufacturing Systems Engineer specializing in automation. This role involves providing technical leadership... ...a Bachelor's Degree in Engineering and relevant experience in GMP environments. Amgen offers competitive salaries, comprehensive...Senior
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