GMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.
GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC, Conductivity, EU WFI Chemical Testing.
GMP review of Qualification and Media Release testing.
GMP review of facility cleaning data and in-processing testing, including but not limited to endotoxin, bioburden, BI, HPLC, Protien Concentration, pH and Osmolality.
Initiation and follow-up of exceeded alert and action limits per procedures.
Participate in preparation of quarterly trending reports
Raw Materials
GMP review of general appearance/identifications and FTIR
GMP review of house gas/air sampling and testing
Initiation and follow-up of OOS and action limits per procedure
Electronic and physical receipt, log-in and distribution of samples and testings materials coming into QC.
Discarding / completing sample custody chain
Preparation and shipping of sample/materials
Aliquoting of bulk samples, assay standards, assay controls and custom assay reagents
Laboratory Support
Assist in updating and writing SOP's
Routine calibration and maintenance of laboratory equipment which includes pipettes, balances, plate readers and pH meters
Cleaning of incubators, laminar flow hoods and biosafety cabinets
Cleaning of refrigerators and cold rooms
Defrosting of freezers
Disinfectant preparation
Maintenance of solvent wash bottles
Cleaning of water baths
GMP lab sweeps
Equipment out-of-tolerance (OOT) and refrigerator, freezer, incubator and pipette investigations
Weekly distributed control system (DCS) documentation review and maintenance
Participate as required in any investigations associated with their deliverables supporting this task order
The Ideal Candidate would possess:
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Minimum Qualifications:
B.S. degree with 1 year of Quality Control experience in the Pharmaceutical industry
Experience in a Quality Control Lab is preferred
Work experience in a cGMP environment is required
Experience with Microsoft Word and Excel is required
Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Position is full-time, Monday-Friday, 7 a.m.- 3 p.m., with overtime as needed. Candidates currently living within a commutable distance of King Of Prussia, Pennsylvania are encouraged to apply.
Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories, please explore our website www.EurofinsUS.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
