Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective Specifications, protocols, Methods and Compendial monograms.
Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.
Maintains cultures according to ATCC and departmental Standard Operating Procedures.
Performs identification of microorganisms using techniques such as API, Gram Stain, etc.
Prepares reagents, standards, Medias, etc. needed for analysis.
May be required to work with potent and teratogenic compounds.
Capable of working under moderate supervision.
Responsible for login of samples (routine and non-routine) into GLIMS database and logbooks
Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks.
Required to perform basic statistics to support analytical testing.
Helps receive, label and store receipts of solvents and analytical reagents.
Logs results into GLIMS database
Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, etc.
May order supplies as needed
Disposes of hazardous waste according to environmental regulations and company/departmental procedures.
Files and maintains laboratory records following Good Manufacturing Practices and as directed through applicable SOPs.
May provide training to new or existing personnel
Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis
Required to maintain and clean laboratory instruments and equipment
Required to read and execute departmental methods and SOPs.
Required to assist in writing, reviewing, or revising procedures and/or laboratory investigations
May be required to clean glassware used to perform chemical and/or microbiological analysis.
Perform other laboratory related miscellaneous duties as required
Required to work shifts in support of the manufacturing process that may include, weekends and holidays. The work hours may change depending on departmental needs.
Requires BA or BS with college course work in related sciences. At least (5) years' experience in an analytical laboratory.
Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required.
Knowledge/Skills Requirements: (Unique knowledge skills or problem-solving requirements.)
Experience with common pharmaceutical laboratory equipment including, but not limited to,
Experience with U.V. spectroscopy
Experience with IR and AA instrumentation
H.P.L.C. and G.C. instrumentation experience
Experience in dissolution testing
Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.
Knowledge of safety and hazardous waste requirements
Knowledge of data acquisition applications and databases
Experience in conducting and writing laboratory investigations
Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Be accessible to manufacturing, laboratory and office staff.
Be able to use required office equipment.
Individual's primary workstation is located in the lab, where the noise level is low.
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed
above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job, but is not a detailed description of all duties which may be
inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status...cont.