Apex Systems Looking for QC Scientist I at Waltham, MA Full Time

Job Scope & Purpose:

Our Waltham-based biotech client is seeking an experienced QC Professional with GMP experience to join their growing team! The position will offer the opportunity to learn cutting-edge laboratory technologies and cGMP analytical skills in a highly collaborative environment. Additionally, the position will also offer the unique opportunity to collaborate with teams in other functional areas across the CMC organization, including Analytical Development, Bioprocess Development, Formulations Development, Molecular Technologies, and Quality Assurance, among others.

Primary Job Responsibilities:

• Work with Facilities and Engineering to support analytical instrument qualification activities.
• Plan and execute method transfers and validations according to the appropriate FDA, ICH, USP and other applicable regulatory guidance.
• Technical support for routine use assays that speak to the product SISPQ.
• Learns proprietary assays and execute as needed to support development, validation, and optimization studies or GMP investigational studies.
• Analyze and record data rigorously and critically; report out analytical results and flag any issues observed.
• Promote analytical and process improvements as a technical subject matter expert.
• Work with QC senior staff to identify and mitigate pain points and/or recognize improvements, promoting a culture of continuous improvements.
• Mentor and train junior staff to execute studies
• Communicate out results of studies or analysis to the key stake holders

Primary Job Requirements:

• BS/MS/PhD degree in the life sciences. PhD, 0-2 years industry experience. MS, 5+ years’ industry experience. BS, 7+ years’ industry experience.
• Team player capable of working in a fast-paced environment; Highly proactive and interested in rapidly learning new skills and helping the team.
• Strong technical writing and communication skills.
• Experience with analytical instrument qualification activities, preferable with knowledge in CSV and Data Integrity requirements, per USP and FDA regulations and guidelines.
• Experience preferred with analytical techniques spanning microbiological assays (i.e. CFU, microscopy, microbiological identification), molecular assays (qPCR, dd PCR, MALDI-TOF), biochemical assays and more.
• Experience with Compendia methods, preferred.
• Previous experience in GMP required.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .