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Aerotek QC Lab Technician in ANN ARBOR, Michigan

Description:

12 month contract to hire!

shift premiums: 2nd shift 10% of payrate - 7% of bill rate 3rd shift 15% of payrate - 13% of bill rate

Second shift openings to start on March 22nd - M-F 3:15pm-11:45pm - train on days 7am-330pm for 1-2 weeks. (we can get 10 in for 3 weeks in a row or 7/8 a week for 4 weeks)

ESSENTIAL FUNCTIONS • Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

• Demonstrates, understands and adheres to company policies, GMP standards and safety procedures

• Informs Manager on progress of projects, transfer of data, process details, etc.

• Executes batch records according to GMP and site quality standards

• Responds to off-hour alarms as assigned by the Manager Manufacturing

• Executes manufacturing cleanroom changeover

• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment

• Supports QA during audits and regulatory inspections

Job Description: *Clean room environment - contractors have to keep product sterile due to risk of contamination. *Sample prep for biologics

 Carry out work in accordance with defined Quality Management System procedures, and support Quality initiatives.  Perform Reagent kit Assembly in accordance with Manufacturing Procedures (MPs), drawings and related Work Instructions (WKI).  Support general Manufacturing objectives.  Support systems development pilot production and experimental work orders, as required  Be committed to following and supporting safety practices.  Prepares for production by reviewing work orders and production schedule, studying and clarifying specifications; managing FIFO (first in first out) as well as part requirements; collect materials and supplies. Set-up equipment necessary for different work orders.  Documents production by completing applicable forms, reports, logs, and records equipment and batches using GDP practices.  Keeps work areas clean and organized  Contributes to Continuous Improvement efforts; Identify and help implement process, procedure, safety improvements.  Complete and maintain training records within expected timelines.  Maintain functional understanding of cGMP's and the impact of deviation from controlled processes and/or procedures. Participate in investigations as needed.  Train/mentor less experienced and new operators.  Maintain inventory; be familiar with Kan Ban, and FIFO. May be required to complete inventory counts periodically.  Completes other tasks as assigned.

Skills:

cGMP, GMP, GLP, fda compliance, fda documentation, good manufacturing practices, good laboratory practices, good documentation practices, Quality control, Laboratory, Qa, Qc testing

Top Skills Details:

If no experience candidates must have:

BS or Associate's degree in biological sciences/biotechnology or related field

If no degree - candidates must have at least High school diploma with the experience below:

•Minimum 1 year of GMP pharmaceutical experience

•Hands-on experience with the installation, operation, cleaning of pharmaceutical GMP equipment

Additional Skills & Qualifications:

MINIMUM EDUCATION, EXPERIENCE, SKILLS:

•BS in biological sciences/biotechnology or related field preferred OR at least High school diploma with the experience below:

•Minimum 1 year of GMP pharmaceutical experience

• Hands-on experience with the installation, operation, cleaning of pharmaceutical GMP equipment

Experience Level:

Entry Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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