QC Analyst

BCforward is currently seeking a highly motivated QC Analyst in Winchester, KY 40391

Job Title: QC Analyst
Duration: 4+months

Location: Winchester KY 40391
Anticipated Start Date: ASAP

(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)

Job Type: Contract (40 hrs. a week)

Pay Range: $27.00hr to $29.08/hr
(Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

SHIFT - MON-FRI 3PM - 11:30PM

"The client is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. It provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Key Responsibilities include but are not limited to:
* Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
* Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
* Builds credibility within the lab group by performing high quality work
* Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
* Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
* Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
* Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
* Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
* Effectively communicates results of own work through discussions and documentation with some input from supervisor
* Flexibility in following unique campaign requirements that may include off-hour and weekend work
* May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.

Experience & Education:
* Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
* Experience working in cGMP Quality Control
* Experience with Microsoft Excel and Microsoft Word
* Strong attention to detail
* Familiarity with Good Manufacturing Practices (cGMPs)
* Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
* Must be able to work off hours or weekends as required
* LIMS or MODA experience a plus
* Experience conducting bioburden and membrane filtration testing a plus

Benefits:
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.
This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Interested candidates please send resume in Word format Please reference job code 234761 when responding to this ad.