Responsibilities
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.
The successful candidate will
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.
Relevant experience
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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