- for testing and coordinating analytical activities associated with raw material, in-process control, release products and stability samples in QC lab.
- data and resolves technical issues.
- analytical method development and validation activities when needed.
- testing schedule to ensure the timely completion of required PD sample testing.
- and approves QC testing forms, on-time completion of document review for completeness, clarity, accuracy to support on-time release of GMP lots.
- safety, quality operation and full compliance of QC lab operation with GMP and quality system requirements and policies including investigation of any OOS/OOT/Atypical Results/CAPA events.
- authors, and edits documents, including deviations, change control requests, SOPs, test methods and related technical reports necessary for laboratory operations.
- up to date and accurate quality control records and lab reports.
- to audit readiness and participates in quality audits with regulatory agencies, and customers, as needed.
- successful candidate should have a degree in Chemistry or closely related discipline with several years of experience (M.S. > 3 years experience, B.S. > 5 yeas experience) in Quality Control and analytical development support of Active Pharmaceutical Ingredient (API). QC experience under GMP environment is required.
- technical experience in the analysis of small molecules, demonstrated knowledge of HPLC, GC, KF, IR and other analytical techniques.
- in the investigation of OOS/OOT results and the implementation of CAPA.
- oriented, possessing excellent analytical and problem-solving skills with a strong sense of purpose and urgency.
- player with well-developed interpersonal, organizational, and communication skills
- to prioritize work in response to company demands while maintaining work quality.
- oral and written communication skills for effective communication internally and externally.
- Medical begins 1st of the month following date of hire for Medical, Vision (Co. Paid), and Dental Insurance
- Co. Paid ~Life Insurance; Short-Term Disability (STD) & Long-Term Disability (LTD)
- ~Holidays, Vacation, Sick Time, and Maternity Leave
- 401K with match
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Scientist / Sr. Scientist - Quality Control - Woburn, United States - Asymchem Group
2 weeks ago
Description
Job Title: Scientist or Senior Scientist – Quality Control
***No 3rd Party Admissions or related inquiries accepted at this time***
Reports To:Director, Quality Control
Location: Woburn, MA (On-site) - Local Candidates Strongly Preferred
Job Type: Full-Time
Company Overview:
Asymchem Boston Corporation (ABC) is part of Asymchem Labs Ltd. founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations, and clinical research services. Asymchem Group, headquartered in Tianjin, P. R. China. is a publicly traded company on the Shenzhen Stock Exchange (stock code SZ)
Job Overview:
Asymchem Boston Corporation is seeking highly self-motivated candidates for QC Scientist/Senior Scientist to join the team in Woburn, MA. The successful candidate will possess an in-depth knowledge of quality control, cGMP and analytical science, to support drug substance development and ensure cGMP compliant practices in the QC laboratory.
Duties & Responsibilities:
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
Benefits:
Our commitment to an inclusive workplace
