usa-compliance specialist ii (manufacturing/quality).

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Framingham, Massachusetts job type: Contract salary: $22.00 - 27.67 per hour work hours: 8 to 4 education: Bachelors   responsibilities: ? Ensures the efficiency of Quality System implemented between company and the sub- contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements. ? Leads projects as assigned such as new product launch teams. ? Identify and leads the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to company products. ? Collaborates with subcontractors to find and implement solutions concerning quality issues. ? Respond to customer complaints, including close out and determination of corrective actions by collaborating with CMO's and identifying trends. ? Identify and prevent or resolve issues that could impact the continuity of supply of existing products. ? Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations. Identify trends to reduce Quality anomalies. ? Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality. Knowledge/Competencies ? Excellent oral and written communication skills in cGMP documentation. ? Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience ? Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship ? The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations ? Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations ? Project management skills   qualifications: ? Bachelor of Science ? 5-7 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry   skills: MS-WORD, MS-EXCEL, MS-Powerpoint, 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Worcester, Massachusetts job type: Contract salary: $28.00 - 30.43 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Performs test methods validations for clinical and commercial projects.Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements.Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements.Performs a multitude of laboratory techniques for which they are trained.Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives.Authors validation protocols and reports as well as corresponding test methods.Support laboratory investigations in a timely manner.Support a variety of testing techniques upon completion of training.  qualifications: BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree and 2+ years of related work experience.CE-SDS, HPLC or ELISA existing experience and troubleshooting experienceEmpower or Softmax / PLA software experience  skills: Quality control, HPLC, Phase iii, Chemistry, 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

How passionate are you about your work? This is an opportunity to connect your work to passionate contributions in the pharmaceutical and biotech industry. This could be a great match for you. Your quality skills and experience could contribute to producing cutting-edge vaccine technologies based on messenger RNA   This position is located at our new GMP Manufacturing site in Norwood, MA. The shifts for this position will be 1st shift: 6 AM - 4 PM; 2nd shift: 2 PM - 12 AM; 3rd shift: 10 PM - 8 AM Shift: First, Second, and Third shift. Swing: Sunday - Wednesday or Wednesday - Saturday Apply today to improve your career, while contributing to improving health. Send your resume to michael.parker@randstadusa.com. Share this opportunity with your similarly-skilled colleagues!  salary: $30 - $35 per hourshift: Firstwork hours: 6 AM - 4 PMeducation: BachelorResponsibilitiesHow passionate are you about your work? This is an opportunity to connect your work to passionate contributions in the pharmaceutical and biotech industry. This could be a great match for you. Your quality skills and experience could contribute to producing cutting-edge vaccine technologies based on messenger RNA Manufacturing Associate I - Manufacturing Operations - Norwood, MA This position is located at our new GMP Manufacturing site in Norwood, MA. The shifts for this position will be 1st shift: 6 AM - 4 PM; 2nd shift: 2 PM - 12 AM; 3rd shift: 10 PM - 8 AM Shift: First, Second, and Third shift. Swing: Sunday - Wednesday or Wednesday - Sunday. Pay: $30 - $35/hour Here’s What You’ll Bring to the Table: BS in a relevant scientific discipline with at least 2 years relevant Quality Control experience in a cGMP organization with a focus in Microbiology Familiarity with relevant and current FDA, EU, USP, ICH guidelines and regulationsThe essential functions of this role include:working in a smoke free environmentworking weekendsSkillsPackagingcGMPInventoryOrder FillingOrder FulfillmentOrder PickingOrder ProcessingMaterial HandlingBiotechBioWorksSAPPurchase OrdersSOPInvoicesLine ManagementvalidationDocumentation of OperationscoherusmedicinePharmaceuticalcovid-19theraputicsbiosciencestesting cellsgrowth promotionkinetic chromogenic endotoxinFDAQuality ControlmicrobiologistassayLaboratory/Sciencesclinical studiesraw materialcritical utilitycell bank teste. colivitek maldimicrobial identificationgrowth promotion testingbioburdensterilityconductivitycarbon analyzerTOC analyzerTOC monitoringtotal organic carbon testingcell stock identityculture purityGMPmicrobiological testingmRNAmicrobiologyManufacturingQualificationsYears of experience: 0 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.