Position Title:

Quality Control Microbiology Associate I

Department:

Quality Control

FLSA Classification:

Salaried, Non-Exempt

Direct Reports:

No

Career Track:

Technicians (T)

Career Level:

3

Primary Function

To perform GMP testing and environmental monitoring to support lot release and in-process testing.

Essential Job Functions/Duties

Perform GMP lot release and in-process testing for microbiology-based methods such as growth promotion, gram stain, and sterility testing in support of manufacturing processes

Perform environmental monitoring activities such as collecting viable air, surface EM samples, non-viable particulate samples, reading of plates and trending for EM data

Use Laboratory Information Management Systems (LIMS) to identify samples to be analyzed and to generate analytical data and enter the data into LIMS

Perform EM data review, trending, and analysis.

Maintain instrumentation and supporting documentation in a GMP compliant manner

Handle and work with microorganisms and maintain facility isolates

Recommend and establish different methods for performing QC Microbiology tasks

Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices and cleanroom etiquette

Conduct microbiology validation studies, assay qualifications and special projects as assigned

Support interdepartmental communications when outside testing is required

Troubleshoots assay methods and equipment

Cleaning and General maintenance of side labs

Aid in activities related to monthly inventories and removal of expired products

Assist in the investigation of nonconformance activities with additional testing and evaluation activities as needed

Author quality system records such as deviations and CAPAs.

Knowledge, Skills, and Abilities

General Skills & Abilities

Exemplifies Cook MyoSite Core Values

Maintain regular and punctual attendance

Must maintain company quality and safety standards

This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.

Ability to work in collaborative and independent work situations and environments with minimal supervision

Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability

Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals

Trainability

Must have effective verbal, written and interpersonal skills

Able to prioritize and operate proactively

Must demonstrate critical thinking and proven problem-solving skills

Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations

Must demonstrate a sense of urgency and being proactive to avoid material shortages.

Must be able to multitask

Computer, Technology, and Technical Skills & Abilities

Proficient knowledge of Microsoft Office software, and other general office equipment.

Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Education/Qualification Requirements

Education:

Undergraduate degree in Microbiology or 6 years direct, relevant experience in Microbiology o provide a comparable background

Experience Preferred:

Minimum of 1-3 years' experience in Microbiology/Laboratory

Preferred Qualifications:

Physical Requirements/Work Environment

Location:

Full Time On Site

Setting:

Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

Physical Requirements:

Quality Control:

Ability to conduct and hear ordinary conversation and telephone communication.

Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

Ability to work under specific time constraints.

Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

Visual and manual acuity for working with computers and equipment.

Ability to spend majority of day standing in laboratory setting or sitting at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.

Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

Travel:

None

Type of Travel:

Not Applicable

Driver’s License Required:

No

Passport Required:

No

Option for Visa Sponsored Position:

Permanent Resident / US Citizen

Training Compliance:

Employee that does not interact with Healthcare Professionals

Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.

Employee’s Signature and Date

Manager’s Signature and Date

Employee’s Printed Name

Manager’s Printed Name

Job Type: Full-time

Pay: $22.10 - $25.75 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Ability to Relocate:

• Pittsburgh, PA 15238: Relocate before starting work (Required)

Work Location: In person