Quality Analyst I
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Careers at Alcresta Therapeutics
Quality Analyst I
The QC Analyst I will implement new and execute existing analytical methods for in-process and final product testing. The QC Analyst I will be responsible for day-to-day operations of the QC lab as detailed below.
PRIMARY RESPONSIBILITIES:
• Perform QC intermediate and finished product release testing
• Receipt and storage of QC test samples and lab chemicals
• Support QC lab calibration activities
• Participate in internal assessments and lab audits as required
• Review QC lab data for product release
• Review QC lab related Work Instructions (WI) and Standard Operating Procedures (SOPs)
• Initiate and investigate NCRs related to QC lab out-of-specifications and failures
• Upload Quality records e.g., Medical Device Records, to Alcresta’s electronic database
• Archive Quality records as needed
• Review data from Contract Manufacturing Organizations (CMO) and external test laboratories, including Medical Device Records as needed
• Assist with Certificate of Analysis preparation as needed
EDUCATION & EXPERIENCE:
• B.S. in Biology/Chemistry with at least 2 years of QC lab experience or associates degree with at least 4 years of QC lab experience
• Experience as a QC analyst in a GMP/GLP biotech/pharmaceutical laboratory preferred.
• Proficiency at Microsoft Word, Excel, PowerPoint is required
• Analytical experience: protein chemistry assay experience (e.g., enzyme activity, A280, BCA, ELISA) preferred. Candidates must be experienced in use of Gilson pipettes, both single channel and multichannel, and pipetting techniques
KEY SKILLS AND COMPETENCIES:
• Strong analytical and quantitative skills
• Excellent organizational skills and attention to detail
• Strong general laboratory and organizational skills, effective communication skills, both oral and written
• Excellent oral and written communication skills to successfully interface with various levels of management, multiple departments and external vendors
• Proven ability to manage time and multiple project priorities effectively, on-time, and on-budget
• Demonstrates personal initiative working independently and confident to seek guidance as needed
• Ability to adapt to changing conditions and experience working in a fast-paced, small company environment
• Proficient Microsoft Office skills (i.e., Outlook, Word, Excel, PowerPoint, etc.)
ADDITIONAL JOB REQUIREMENTS:
• May require support during off-hours and/or holiday shutdowns.
• Candidates must successfully complete all required pre-employment screenings, including background checks and drug testing, in accordance with Company policy and applicable law.
• Location: Corporate Headquarters – Waltham, MA
Anticipated salary range: $60,000-$70,000