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job summary: Primary responsible for quality oversight of GMP documents related to site startup activities. Some of these activities include reviewing and approving GMP documents, communicating with site SMEs for document adequacy, communicating action progress to Sr Manager level.   location: Apex, North Carolina job type: Contract salary: $30.00 - 37.96 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Candidate will be responsible for; ensuring GMP documents are accurately reviewed and approved in the applicable GMP system in a timely manner, triaging documents to determine adequacy against requirements, follow-up communication with functional SMEs for additional information on GMP documents, completing approvals per required timeframes and providing responses to the Sr Manager level.Candidate will also be responsible for working with other Company departments.Additional responsibilities include prioritizing documents and understanding the importance of accurate review process within the required timeframe, and performing other duties as assigned by supervisor.  qualifications: Required: Doctorate Degree OR Master's + 3 years relevant experience OR Bachelor's + 5 years relevant experience.5 years biopharmaceutical experience in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing.Understanding of biopharmaceutical bulk manufacturing and distribution processes.General knowledge of cGMP and filing regulations, practices, and trends (manufacture, testing, distribution of biopharmaceuticals).Self-motivated; interfaces effectively at various levels; attentive to details; understands accuracy/precision.Prioritizes and meets deadlines.Excellent leadership, problem-solving, analytical, and customer service skills for a matrix-managed GMP environment.Well-organized; excellent oral and written English communication skills.Focuses on process improvements.Manages a large number of complex assignments simultaneously.Functions in a fast-paced environment.Evaluates issues, makes quality decisions, and knows when to escalate.Strong project management skills; works in cross-functional teams; handles multiple projects simultaneously.Works effectively in a team-oriented environment with diverse groups.Computer literate; understands/follows/implements instructions independently.Collaborates with outside resources.Possesses outstanding attention to detail and organization skills.Possesses effective decision-making skills. #LI-PV1   skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

job summary: The QC Chemistry Specialist plays a critical role in ensuring the successful establishment and ongoing support of the Quality Control Chemistry laboratory in a GMP-regulated environment. This individual is responsible for leading laboratory readiness efforts, overseeing analytical method transfers and validations, and ensuring compliance with data integrity and regulatory expectations. The QC Chemistry Specialist functions as a subject matter expert (SME), providing technical and operational guidance while driving continuous improvement.   location: Apex, North Carolina job type: Contract salary: $35.00 - 42.21 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Lead QC Chemistry activities, including analytical instrument qualification, method transfers, and validation of laboratory systems and processes.Review and contribute to validation documentation supporting onboarding of equipment and computerized systems.Author, revise, and review a range of technical and quality documents, including SOPs, test methods, qualification protocols/reports, method and technical assessments, and trend reports.Support procurement and readiness of laboratory consumables and critical reagents for lab operation.Coordinate and execute training and method transfers for chromatography-based methods (HPLC, UPLC), TOC, and related bench-top analytical instrumentation.Own and manage Quality System records, including Deviations, CAPAs, and Change Controls.Support internal and external audits and represent the QC Chemistry function in cross-functional and global initiatives.Provide operational support for testing or system needs during weekends and public holidays, as required.  qualifications: Required Qualifications: Bachelor's degree in chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.Minimum of 4 years of QC or analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.Proficient in chromatography techniques (HPLC/UPLC), TOC analysis, and general laboratory instrumentation.Experience with analytical method validation, transfer, verification, and equipment qualification.Demonstrated ability to manage quality records (e.g., Deviations, CAPAs, Change Controls) independently.Proficient in laboratory systems such as LIMS and electronic quality systems (e.g., LMES/CIMS).Strong understanding of regulatory and industry compliance standards, including data integrity principles.Excellent technical writing and verbal communication skills.Proven ability to work independently and collaboratively in a fast-paced, dynamic environment. Preferred Qualifications: Experience supporting new laboratory startup or facility buildout projects.Prior participation in regulatory inspections or third-party audits.Familiarity with ICH guidelines and USP general chapters relevant to chemical analysis.  skills: Quality control, HPLC, SOP, Analytical Chemistry, Chemistry, Chromatography, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

job summary: This position will support QC ELN Project, including but not limited to, system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification and masterdata templating associated with Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure).   location: Telecommute job type: Contract salary: $40.00 - 44.91 per hour work hours: 9 to 5 education: High School   responsibilities: Support validation/qualification deploymentLead eProcedure qualification in LMES in support of Global QC Method Specific eProcedure creation/qualification project.Manage CIMS template creation for Global QC method specific reagents/ and ANC consumables.Provide incident management support as required.Support application performance monitoring and label printing issues.Identify operational gaps and propose solutions.Assist in the execution of QC Laboratory Systems equipment integration for all ANC QC Laboratories.Responsible for training the Company's NC site as each QC Laboratory systems go live in the production environment.Author, revise, and review documents and reports including SOPs, qualification reports, technical reports.Lead planning, scheduling, and execution of QC Laboratory Systems daily activities.  qualifications: Required: Doctorate degree OR Master's degree + 2 years experience OR Bachelor's degree + 4 years experience OR Associate's degree + 8 years experience OR High school diploma / GED + 10 years experienceQuality Control Systems implementation experience in the pharmaceutical industry.LIMS experience is a must have #LI-HK1   skills: Quality control, SOP, Laboratory Information Management Systems (LIMS), LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay 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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.