Quality Control Microbiologist
Quality Control Microbiologist
La Mirada Office
Summary: Quality Control Microbiologist primarily provides support to QC laboratory. They are delegated to test all incoming Drug substances, raw materials, manufacturing aids, closures and packing materials per compliance to CGmp, Captek SOPs and Test Methods.
Essential Duties and Responsibilities include the following. Other Duties may be assigned.
- Per compliance to cGMP, Captek SOPs and Test Methods, and training, accurately and appropriately performs laboratory tests such as plating, streaking, performing MPN, incubating, and identifying and counting, while properly documenting and reporting the performed test in assigned laboratory notebooks, test reports, and other such relevant documents.
- Assist Microbiology Technician with Microbial Limits Test(MLT), such as plating, streaking, performing MPN, incubating, and identifying counting.
- Prepares all broth for MLT analysis and performing all associated testing, including Growth Promotion Test. Purchases all prepared agar media for MLT analysis as well as necessary equipment, supplies, and inventory for QC Microbiology.
- Performs MLT on water sample collected in production area and ATP swab test on equipment in production.
- Maintains all equipment in the QC Microbiology Laboratory including scheduled maintenance, calibration, necessary daily check, etc.
- Generates the necessary SOPs and test methods for QC Microbiology.
- Generates protocols and execute to ensure proper testing and methodologies of protocols, respective of Captek’s quality systems.
- Serves as back-up in the absence of the Microbiology Technician and have the knowledge to perform their duties.
- Develop and maintains seed-stock colonies for positive control as well as control transfers from ATCC stock strains. Practice high quality Aseptic Techniques at all times.
- Notifies supervisor in an appropriated and timely manner when out of specification test results occur and cooperates in the investigation.
- Interacts with technicians and other chemists, while sharing common work areas to ensure proper communication and smooth work-flow.
- Adheres to all safety,cGMP, and Captek’s Standard Operating Procedures, particularly those of the QC department, while partaking in the accountability of all QC staff to do the same.
Quality Control Microbiologist must have the ability to be flexible, handle multiple projects simultaneously and adjust personal style to adapt to increased business pressures and work well under pressure.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.
Minimum of Bachelor’s degree in Microbiology (or related field dependent on degree of experience)
Minimum 4 to 5 years of experience in microbiology lab of a Pharmaceutical or related industry.
Basic laboratory techniques and basic knowledge of cGMP
Ability to read and understand SOPs, methods and test procedures. Ability to respond to common inquiries by co-workers, auditors and supervisory personnel as well as communicating with suppliers and vendors, and contract laboratories.
Ability to comprehend and apply principles up to mathematical calculations and algebra. As needed ability to work with concepts such as limits, fractions/percents, orders of operations, ratios, and conversions.
Ability to apply basic principles of logical or scientific thinking situations encountered during the course of work in the QC department. Ability to deal with nonverbal symbolism (formulas, mathematical equations, etc) in simple phases.
To perform this job successfully, an individual should have knowledge of:
Internet, Word, Excel, SysPro
Certificates and Licenses:
The work environment characteristics described here are representative of these an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to toxic and/or caustic chemicals such as Sodium Hydroxide, Hydroelectric Acid, M ethylene Chloride, Hydrogen Sulfide Dilutions, and more. There is a risk of electrical shock if proper machinery procedures are not followed as well as the dangers of possible burns from chemicals, fires, and combustion reactions as well as explosions. Safe work practices and proper handling are essential to the success of this position as well as the safety of all staff members of the laboratory.The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essentials functions.
The employee must regularly lift and/or move u to 25 pounds.
Specific vision abilities required by this job include: Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is regularly required to use hands and fingers to feel and reach with hands and arms. The employee is frequently required to stand; walk; sit and talk or hear. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
To perform the job successfully, an individual should demonstrate the following competencies
· Analytical – Demonstrates attention to detail.
· Problem Solving – Identifies and addresses problems in a timely manner, works well in group problem solving situations; uses reason even when dealing with emotional topics.
· Technical Skills – Assesses own strength and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
· Interpersonal – Focuses on solving conflict, not blaming, maintains confidentiality, listens to others without interrupting; keeps emotions under control; remains open to others’ ideas and tries new things.
· Oral Communication – speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; responds well to questions; Participation in meetings.
· Team Work – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ view; Gives and welcomes feedback; Contributes to building a positive team spirits; Supports everyone’s efforts to success-ed; Recognizes accomplishments of other team members.
· Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; presents numerical data effectively and accurately; Able to read and interprets written information.
· Quality Management – Demonstrates accuracy and thoroughness.
· Diversity – Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.
· Ethics – Treats people with respect; Upholds organizational values.
· Support – Follows policies and procedures; Supports organization’s goals and values.
· Adaptability – Adapts to changes in the work environment; Able to deal with frequent change, delays, or unexpected events.
· Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; arrives at meeting and appointments on time.
· Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.
· Accountability – Upholds own responsibilities while keeping others engaged with the task requested in cases of collaborative work.
· Initiative – Volunteers readily; Undertakes self-development activities, seeks increased responsibilities; asks for and offers help when needed.
· Judgment – Exhibits sound and accurate judgment; supports and explain reasoning for decisions.
· Planning/Organizing – Prioritizes and plans work activities; uses time efficiently; plans for additional resources; keeps area organized and structured so as to adequately manage tasks.
· Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
· Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promotes quality; Applies feedback to improve performance; Monitors own work to ensure quality.
· Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
· Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.