- Catalent (Manassas, VA)
- …and any other standard Catalent complies with; Responsible for ensuring compliance to FDA and cGMP standards for Quality Control , including continuous training. ... POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection and verification...appropriate details; Report any housekeeping issues that need attention. Document all areas of non-compliance and ensure corrective actions… more
- Bristol Myers Squibb (Bothell, WA)
- …no better place than here at BMS with our Cell Therapy team. The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document ... to an effective state. + May write and revise document control procedures including participating in the...of 1 year of relevant labeling experience in a cGMP/ FDA regulated environment. + Minimum of 1 year utilizing… more
- Actalent (Stratford, CT)
- …smoothly within a devoted team Skills: qa/qc, batch record review, gmp, fda , pharmaceutical, medical device, coa, cmp, capa Top Skills Details: qa/qc,batch record ... review,gmp Additional Skills & Qualifications: + Bachelor's degree in science related field (MS preferred) + 2+ years in like or similar function in pharmaceutical or medical device industry cgmp + Strong communications skills and proficiency with the English… more
- Actalent (Maryland Heights, MO)
- …Prepare logbooks and issue logbooks and notebooks for use across the site. Skills: document control , microsoft office, fda , gmp Top Skills Details: ... Description: The Contract Quality Systems Documentation Specialist is responsible for assisting in the management...document control ,microsoft office, fda ,gmp Additional Skills & Qualifications: Associates degree preferred, High… more
- Immediate Mailing Services (Liverpool, NY)
- Quality Control Production Specialist Department: Compliance Reports to: VP of Compliance Location: Liverpool Full-Time: Monday - Friday, 8:30 am to 5:00 pm Pay ... end of the pay band. Position Summary The Quality Control Production Specialist is a role that...compliance with industry standards, regulations, and certifications (eg, ISO, FDA ). + Train production staff on quality control… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …pertaining to shared/impacted processes. + Communicates with Training Department and Document Control to facilitate Center and Corporate training related ... role based out of our RTP, NC office.** **Summary:** Processes change control requests to ensure that process and documentation changes with the potential… more
- Teleflex (Chelmsford, MA)
- …technology solutions that make a difference in patients' lives. **Position Summary** The Document Control & Records Specialist will support the Quality ... Documentation Control and Records Specialist **Date:** Jun...will be responsible for daily support activities related to document control and archiving. In this role… more
- Charles River Laboratories (Mattawan, MI)
- Quality Control Specialist , Laboratory Sciences Req ID #: 221813 Location: Mattawan, MI, US, 49071 For 75 years, Charles River employees have worked together to ... currently seeking a **Data Analyst II** for our **Quality Control ** team located at our **Mattawan, MI** site. **Quality...not limited to, those listed: + Efficiently perform and document all procedures, materials and results in compliance with… more
- Boehringer Ingelheim (St. Joseph, MO)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex validation ... for assuring compliance of validated systems, process, equipment to current cGMP, FDA , EU, USDA, BIAH and BI corporate requirements. This includes, but is… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational goals.. + Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global ... industry practices, and standards. + Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the...biologics manufacturing and a BS or BA, with change control experience a must. + 4+ years of relevant… more
- Kelly Services (San Jose, CA)
- …responsible to provide general quality assurance support in the areas of inspection, document control and the overall maintenance of the quality management ... **Quality Assurance Specialist ** **San Jose, CA** **Full-Time** **1** **st** **Shift**...Control experience preferred. + Working knowledge of the FDA medical device Quality Systems Regulations and international quality… more
- J&J Family of Companies (Skillman, NJ)
- …, Investigation, Corrective Actions and Preventative Actions (CAPA), Metrics, Training and Document Control . The Quality Control role is responsible ... Quality Systems Specialist - 2407021304W **Description** Kenvue is currently recruiting...(SME) for the Training system as well as the Document Control Process (Tru). You will also… more
- STERIS (St. Louis, MO)
- …820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection ... Quality Specialist Req ID: 44372 Job Category: Quality St....support the site Management Review process. Duties + Complete document control transactions. + Manage Customer complaint… more
- STERIS (Eden Prairie, MN)
- …820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection ... Quality Systems Specialist Req ID: 41702 Job Category: Quality Eden...and help write your next chapter. Duties + Complete document control transactions. + Manage Customer complaint… more
- STERIS (Plymouth, MN)
- …820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection ... Quality Specialist Req ID: 43014 Job Category: Quality Plymouth,...support the site Management Review process. Duties + Complete document control transactions. + Manage Customer complaint… more
- Stryker (District Of Columbia, DC)
- …employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/ document /2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Stryker is ... at www.stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist ** to join our **Spine Division** based **Hybrid** in Allendale, New… more
- Unither Pharmaceuticals (Rochester, NY)
- …control committee meetings, training, and coaching site employees on the change control process. In addition, the Quality Systems Specialist will support ... Quality Systems Specialist Who we are? We are a French...be responsible for the oversight of the site change control system which will include facilitation of the change… more
- Bristol Myers Squibb (Devens, MA)
- …process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility. **\#LI-ONSITE #BMSBLDMA** If you come across a ... in their personal lives. Read more: careers.bms.com/working-with-us . The Specialist , Validation Engineer I supports the successful implementation of manufacturing,… more
- WuXi AppTec (Philadelphia, PA)
- …as: Assay Validations, Process Validations + Stay current with changes to GXP, including FDA and EU and other regulator bodies as well as guidance documents (ie: ... are adequately translated into MFG records. + Work with document reviewers to compile and review raw data, batch...requests. + Equipment Validation (IQ, OQ, PQ) and Change Control review/approval. + Participate in quality and process improvement… more
- Digital Prospectors (Boston, MA)
- …through meticulous review, validation, and verification processes. + Establish and manage document control protocols to govern version control , access, ... **Regulatory Documentation Specialist ** **Boston, MA** **Job Type:** Contract **Recruiter:** Jaime...standards, and guidelines applicable to the industry, such as FDA regulations, ICH guidelines, and ISO standards. + Strong… more
