Qc Associate I

Profile

We are seeking a Qc Associate I for a very important client.

The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market.

Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world!

How will you make an impact?

This position will work in the cGMP compliant QC Microbiology Laboratory supporting manufacture of biological products. Responsibilities include performing and providing support for functional aspects of the facility such as environmental monitoring (EM), microbiological testing (bioburden, bacterial endotoxin testing, growth promotion, biological indicators, stock cultures), media fills, water testing and validation support.

The incumbent will be expected to interpret controlled documents and reports, and review data produced by self and initiate investigations. Will interact with other departments to ensure that environmental monitoring scheduling and sample flow, are correctly maintained.

Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Will assist with qualifications (equipment, media, clean room, etc.).

What will you do?

Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling
Perform microbiological testing such as bioburden, bacterial endotoxin and biological indicator testing.
Order laboratory supplies and maintain required inventory according to SOPs
Perform laboratory and equipment cleaning and preventive maintenance and calibration
Read and report microbiological test results
Perform Gram stains and arrange shipments of samples to contract labs for identification
Maintains and ensures safe laboratory practices.
Other assigned duties could include sample logging and assisting with shipment preparations
Documents revision
Work performed would support GMP manufacturing activities and release testing. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.
Requirement:
The ideal candidate will possess the following qualifications:

How will you get here?

Minimum of a High School diploma. A minimum of two years of work experience of at least one year lab experience in biological and/or pharmaceutical industry.
Knowledge, Skills, Abilities

Electronic organizational skills using Microsoft Excel, Word, Power Point or other planning tools
Basic knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment
Strong attention to detail and ability to adhere to standards procedures
Ability to function in a rapidly changing environment
Problem-solving and critical thinking skills
Ability to communicate/work in a high pressure/high paced environment
Ability to multi-task and function effectively as a member of a team
Excellent writing, communication and presentation skills
Ability to drive functional, technical and operational excellence
Ability to read and interpret technical procedures or governmental regulations.
Ability to recognize and escalate when a decision is required for choosing between limited alternatives to resolve problems of moderate complexity.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to speak effectively before groups of employees.
How to Apply:
If this position is a fit, simply click on the recruiter's email above, attach your resume, and hit send.

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Company info

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