A&QC Specialist II - Toronto

Job#: · Job Description: · Title: · ANALYTICAL & QUALITY CONTROL SPECIALIST II - ENVIRONMENTAL MONITORING / MICROBIOLOGY · Client: · Biotechnology company · Contract/Perm & duration: 12-month contract (possibility of extension/conversion) · Location: · Toronto, Onsite Monday- Fri ...

Job description

Job#:

Job Description:

Title:
ANALYTICAL & QUALITY CONTROL SPECIALIST II - ENVIRONMENTAL MONITORING / MICROBIOLOGY


Client:
Biotechnology company

Contract/Perm & duration: 12-month contract (possibility of extension/conversion)


Location:
Toronto, Onsite Monday- Friday


Pay Rate:
$26-30/hr (T4)


Description of Position:

The Analytical & Quality Control (A&QC) Specialist II - Environmental Monitoring (EM) / Microbiology will perform various EM-related activities according to internal SOPs and policies that provide regulatory compliance and maintain control around the quality of product manufacturing.

In addition to the EM program, the specialist will assist and perform microbiological testing of cell therapeutics for pre-clinical studies and human clinical trials.

The specialist will help with technical and administrative support related to GMP clean room environmental monitoring and documentation, design and maintain an EM program for GMP compliance, support with effective collaboration and liaise with GMP Manufacturing team to ensure EM support is provided.

Duties will also include routine laboratory maintenance, equipment checks and maintenance, reagent preparation and analytical testing support as required.


Responsibilities:

Perform EM sampling in a cleanroom setting and testing in accordance with internal policy and SOPs and ensure the use of proper aseptic technique during execution.

Knowledgeable with EM lab equipment and techniques (SAS, Climet Particle Counter, viable airborne monitoring (active and passive), viable surface monitoring, and personnel monitoring) and regulatory guidance pertaining to EM.

Perform EM plate incubations and plate enumeration to attain final viable EM results.
Execute Microbiology testing in A&QC laboratory (Endotoxin and Sterility (BaCT/Alert)), including instrument and equipment, support drafting and revising SOPs.
Liaise with external CROs used to perform microbial identification
Review data for accuracy and compliance to specifications, reporting errors to supervisor.
Maintain microbiological EM database and prepare trending reports.
Perform training of aseptic gowning to fellow employees and perform gowning qualifications in controlled classified cleanroom areas.
Train team members to ensure competency in assigned laboratory activities

Assist with internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner.

Occasional weekend work on an as-needed basis.
Perform other general duties as required.


Minimum Requirements:

BSc in Life Sciences with minimum 3 years (Bachelor's) relevant experience in Microbiology, Cell Biology, Genetics, Biotechnology, or related field.

Minimum 2 years of wet-lab experience, displays a good understanding of and proficiency in EM, clean room control strategy, aseptic techniques and other pharmaceutical microbiology lab activities.

Experience in one or more of the following areas is preferred: Microbiology/EM, Endotoxin, Sterility (BaCT/Alert), Mycoplasma (BioFire), pH and Osmolality, aseptic process and media-fill qualification and LIMS.

Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.

Excellent written and oral communication skills, with keen attention to detail and highly organized.
Demonstrated flexibility in adjusting to changing priorities and schedules.
Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.
Occasional weekend work on an as needed basis may be required.

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 uses a virtual recruiter as part of the application process. Click here for more details.

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.

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 uses a virtual recruiter as part of the application process. Click here for more details.

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.

Apex Systems is part of the Commercial Segment of
ASGN Incorporated.


NYSE:

ASGN
4400 Cox Road

Suite 200

Glen Allen, Virginia 23060

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 Benefits Department at [email protected] or Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.