Specialist, Microbiology Analyst

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
MAJOR DUTIES AND RESPONSIBILITIES
Performs laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal / external customer satisfaction.
- The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured.
- In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.),
- The tasks are: preparation and sterilization of materials needed for the analysis such as culture media and the depyrogenation / sterilization of glassware.
- Environmental surveillance of aseptic and oral dosage form manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring.
- Generates environmental trends and graphs of the controlled environments, post then in the manufacturing areas and discuss them with manufacturing personnel.
- Audit of aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required.
- Audit the controlled areas and utilities physical conditions (house-keeping) and generates audit corrective actions if required.
Trains the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques. Oversees sample collection from production areas if manufacturing operators are responsible to perform the task. Generates Microbiology /Chemistry Laboratory Investigations Reports (MLIR) and assist in the investigation of out of levels, out of limits and out of trends. Understands, interprets and applies compendial testing. Operates laboratory equipment (such as air viable monitoring instruments ; non-viable monitoring devices for particulate matter analysis, Vitek, Micro-seq or other similar equipment use for microbial identification; microscopes; Laminar Flow Hoods and Biosafety Cabinets for the handling of biohazardous material; autoclaves; glassware washer; ovens; incubators, refrigerators; freezers; microplate readers; chart recorders, balances and pH meters, UV, density meter ,conduct meter and other microbiology laboratory equipment. Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas and contact as necessary the calibration department or equipment maintenance supplier to assure equipment is calibrated and that the necessary preventive maintenance has been performed. Performs necessary preparations of materials, tests in alignment with Technical Services schedules, validation protocols and special testing requests. Generates as required test summary tables. Maintains accurate records of all work performed and document test results as per Good Documentation Practices. Maintain laboratory logbooks and worksheets as per cGMP requirements. Documents sample related information/sample custody and results in the Laboratory Information Management System (LIMS). Maintains laboratory work areas in clean and organized conditions apply in 6S program tools to organize and improve laboratory work flow and efficiency and sustains the application of the 6S tools in the work area. Originates purchase orders for the materials needed for the laboratory operation and maintains the inventory. Assure that materials stored in the laboratory are within their expiry period. Follows internal inventory system and documents received and discarded material. Maintains a safe work environment and use required safety equipment. Reviews data results for accurateness in alignment with current good documentation practices and internal procedures. Executes test method, process validation and equipment validation test as per corresponding protocols. Reviews documents and generates the necessary red line document and change requests. Assures to be qualified and trained in the applicable procedures required to perform this job duties/responsibilities and; keeps organized personal training qualification record. Supports the Annual Product Review data gathering. Supports the completion of microbiology related CAPA's Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories for the disposition of products and / or raw materials. Assures that stability studies performed at the site follow specific protocols and procedures. Ensures that stability data supports the retest /expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies.
- Ensures an effective process /system for disposition of raw materials, API's, packaging and labeling materials in his functional area.
DECISION MAKING
- Some decision making of a non-critical nature is required of this position.
- Decisions will be made after consulting the Supervisor such as continue with a sample analysis when the area conditions are lost, or not taking a sample when the area is not available and if not taken the due date will not be accomplished.
- Need to rephrase in order to cover the oversight of the manufacturing areas.
- This position requires supervision from the Microbiology Laboratory Manager and / or Supervisor.
- Some flexibility is given in order to promote independence and initiative.
CONTACTS
- Frequent contact with personnel from: Manufacturing, QA, Product Release and Technical Services Areas.
- Sporadic contact with personnel from other departments, such as: Engineering, Finance and Planning,
- Sporadic contact with: Quality Control Laboratories in New Brunswick & Syracuse or other BMS plants outside Puerto Rico.
- Occasional interaction with internal/external auditors, governmental agencies (FDA, MCA, etc.) and other business related groups.
- Occasional contact outside the plant with vendors.
KNOWLEDGE / SKILL
- Bachelor Degree in Biology, Biotechnology, Medical Technology, Microbiology or Industrial Microbiology.
- One (1) year of working experience in a Microbiology Laboratory of a Pharmaceutical Industry.
- Knowledge in laboratory aseptic procedures in a pharmaceutical industry.
- Knowledge of compliance requirements, cGMP, GLP and FDA regulations and the ability to interpret and apply them.
- Communication skills: foster open communication, active listening and good communication skills in English and Spanish (oral and written).
- Self starter with strong analytical and self-management skills.
- Able to act with integrity, adaptability and self-development.
- Knowledge in PCs (Words, Excel, Power point)
- Technical Skills: Knowledge in general laboratory instrumentations such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, Biohazards, UV, densitometer, conduct meter and Laminar Flow Hoods
- Accurate visual inspection is necessary for the recognition of positive microorganism growth
- 20/20 visual eye accuracy with or without correction and good perception of yellow color
- Approve with pass the sight screening test established within the Microbiology Standard Operating Procedure (SOP)
WORKING CONDITIONS
- The incumbent must be fully aware of potential exposure to situations that can impact the performance, efficiency and safety, such as accidents, the handling of potentially toxic products, equipment failure, shortage of materials, unnecessary re-tests and any other situation that may affect the accomplishment of established objectives.
- Require working with hazardous chemicals and biohazardous materials.
- Use of microbiology /chemistrylaboratory related equipment such as autoclaves, glassware washers, microscopes, air monitoring devices, culture media, glassware ,microbial stock cultures, UV, densitometer, conduct meter.
- Use of the require safety equipment such as, gloves, closed safety shoes, laboratory coat, half and/or full mask.
- Light physical exertion and moving up to 25 pounds.
- Able to qualify to work within aseptic environments facilities. This includes thorough cleaning of hands with germicidal soap; use of sterile garments and goggles that covers the entire body including the face; use and tolerate / withstand the use of sanitizing agents such as IPA, hydrogen peroxide, phenolic and sodium hypochlorite solutions.
- Able to enter confined spaces.
- Able to work weekends and second and / or third shifts.
B. Travel required ( describe nature and frequency ):
- Position may require travel both within and outside Puerto Rico. This accounts for approximately 1.0 % of working month.
C. Overnight absences required ( per typical month ):
- Position may require overnight travel that may reach a frequency of one (1) day every two months on average.
- Able to consistently show the following Core Behaviors: Leads Strategically, Communicates Directly, Drives Performance, Team work, innovate, Develop and energizes people.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1539310
Updated: 2021-05-11 01:01:23.200 UTC
Location: Manati, PR
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.