CW Sr Associate QC (Senior)

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Review protocols and perform assay validation and equipment qualification/ verifications when required.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results.
• May interact with outside resources.
• LIMS data coordination of commercial and import testing on site where applicable
• May represent the department/organization on various teams. May train others.

• Be very proficient in the use of Microsoft Word, Excel etc.
• Have strong communication and technical writing skills.
• Investigation skills
• Be detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
• Be a self-starter and capable of working on own initiative.
• Strong teamwork skills.
• Proven track record of meeting deadlines.
• Experience with analytical techniques such as Compendial testing would also be advantageous

• Bachelor's degree in a Science related field is required.
• 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Berkley Group