Job#: 2085737

Job Description:

Environmental Monitoring GMP Specialist

Apex Systems is a large staffing and consulting firm and we are looking for 4 EM GMP Specialists with 2-4 years of experience working in aseptic techniques/clean rooms, working knowledge of GMPs, experience with cell culture for mammalian cells, and some knowledge of Environmental Monitoring to place at our Biotech client.

Client: Innovative Biotech client

Contract/Perm & duration: 4-month contract (possibility of conversion or extension)

Location: Hamilton

The successful candidate that will be selected to support the QC Microbiology Laboratory would be an experienced individual in the field of manufacturing, able to adhere and demonstrate the principles of Good Manufacturing Practices (GMP). The successful candidate will be required to work specifically to maintain the environmental conditions in clean rooms by performing environmental monitoring (EM), as well as associated testing (ie. gram staining, subculturing, organism identification etc) and sample management, including reconciliation and result recording. The successful candidate will demonstrate flexibility within Microbiology team and larger organization, flowing to work priorities, as required. Environmental monitoring (EM) is an enabling function and, as such, this role will support production, and facility needs to ensure business needs are met.

Responsibilities:

• Delivers microbiology-related services including environmental monitoring, sample management, testing, and equipment management.
• Collaborates with the Production team to support the requirements of sampling to align with the production schedule
• Maintains the EM program including (but not limited to): ensuring scheduling of all Grade A, B, C and D samples to meet the sample collection frequency requirements as set forth by internal procedures, ensuring samples are read and documentation is submitted in a timely manner
• Manages sample management to the third-party testing by approved testing partners
• Performs aseptic gowning qualification and maintains personnel qualifications.
• Provides in-suite and on-the-floor support for OmniaBio’ s manufacturing teams, where applicable
• Ensures all EM documentation is complete and available for approval ensuring the highest quality of data integrity are met utilizing good documentation practices (GDP)
• Assist with maintaining equipment and laboratory cleaning schedules as deemed appropriate by internal governing standard operating procedures (SOPs)

Key Qualifications:

• Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.). Microbiology background is preferred.
• 2-4 years of industry experience in a cell therapy/viral quality department supporting GMP production or similar within the pharmaceutical, medical technologies, biologics or similar industries.
• Strong understanding of aseptic/sterile environments and technologies.
• Excellent understanding GMP regulations and good laboratory practices (GLP) and GDP principles.

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 [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.