QC Microbiology Supervisor Position Available In Erie, New York

QC Microbiology Supervisor Pine Pharmaceuticals – 3.6 Tonawanda, NY Job Details Full-time $65,000 – $75,000 a year 18 hours ago Qualifications Microsoft PowerPoint 7 years Microbiology Microsoft Excel Laboratory experience GMP Windows Microbiology High school diploma or GED Bachelor’s degree QA/QC Data entry Contracts Environmental monitoring Computer skills Senior level Associate’s degree Leadership Communication skills FDA regulations Time management

Full Job Description Position Summary:

Responsible for all microbiological aspects in the laboratory, including regulatory compliance relating to Quality Control to ensure that the manufacturing environment, processes and products are within specification. Provides Microbiology expertise via active participation in cross-functional teams, including recommendations on process and procedure improvements that drive QMS efficiency and effectiveness. Performs oversight of various microbiological sampling and testing in an FDA regulated environment, as well as supporting validations for new testing methods and equipment.

Essential Functions:

Supervises departmental work projects both routine and non-routine to appropriately prioritize laboratory workload to meet client requirements as related to quality and turnaround time.

• Maintain efficient functioning of the Microbiology Department.
• Ensure the maintenance of records of all testing is performed.
• Ensure calibration, maintenance, validation and requalification of Micro Laboratory equipment is performed within GMP, regulatory and legislative compliance requirements.
• Ensure safe and good work practices in the laboratory.
• Develop and assess Microbiological Testing procedures of materials and products, ensuring all GMP, Safety, Company, Regulatory, and Legislative compliance requirements are met.
• Review and develop environmental monitoring programs and actions from data trending analysis.
• Prepares and presents departmental metrics.
• Mentors and supervises direct reports and ensures there is an effective training program.
• Ensures all work performed is compliant with Standard Operating Procedures, Current Good Manufacturing Practices, Regulations of the Food and Drug Administration and Pharmacopeial Methodologies.
• Performs timely reviews of direct reports.
• Delegates and reviews Investigative protocols.
• Provides audit responses as required.
• Review of microbiology laboratory investigations including but limited to nonconformances and OOS/OOT.
• Provide communication and interaction with QC/QA management.
• Approval of microbiology/laboratory procedures and documentation.
• Develop processes to assist in quality assurance and contamination control.
• Utilization of a Quality Management System (QMS) for training and document review/ improvements.
• Oversight/Review/Approval including but not limited to product validations, SOPs, Environmental monitoring, media fills and finished goods testing.
• Participates in continuous improvement efforts including cost savings and process changes within the department.
• Lead and mentor the team to ensure cohesion, good morale and productivity.
• Responsible for promoting and maintaining a safe working environment.
• Responsible for assisting in the cleanliness and upkeep of the laboratory.
• May perform other duties as qualified/assigned.

Education and Experience:

• Bachelor’s Degree in Microbiology/Biology or related field and minimum of 7 years of relate

Education and Experience:

Bachelor’s Degree in Microbiology/Biology or related field and minimum of 7 years of related experience (working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry), or an Associates Degree in Microbiology/Biology or closely related field with a minimum of 10 year of related experience. In Lieu of a degree, may consider candidates with a High School diploma (or equivalent) with a minimum of 15 years of related experience. Experience in leading highly effective teams as well as strong leadership skills, attention to detail, business acumen and a passion for quality. Must be results oriented with a proven track record. Experience with QA/QC responsibilities of a 503B outsourcing facility producing commercial products is preferred.

Knowledge, Skills and Abilities:

Accurate/legible completion of records and documents for tests performed, and accurate computer data entry. Technology Skills (Windows, Word, Excel, Power Point). Good communication including verbal and written communication.

• Good time management skills, attention to detail, ability to adhere to implemented standard operating procedures/policies, ability to communicate professionally with contract laboratories regarding sample testing, communication with others, and flexibility for new opportunities/tasks.
• Works well independently while maintaining a team-oriented mindset.

Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology. Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial Enumeration testing methods. Training to ISO, USP or GMPs standards. Strong prioritization and planning skills Builds effective and high performing teams Interpersonal savviness and ability to collaborate. Strong project and change management ability