Quality Lab Associate I - Environmental Monitoring (12pm-12am)

Baxter•Marion, NC

About The Position

The Quality Lab Associate I supports Baxter’s environmental monitoring program by performing surface testing, viable air monitoring, air total particle counts, routine risk assessments, and HEPA filter inspections in clean rooms. The role also conducts microbiological analyses of raw materials, in-process materials, and finished products; collects and records laboratory data; and completes testing according to local procedures and cGMP regulations. The associate helps maintain data integrity and regulatory compliance, reviews environmental events and deviations, and works with Quality Operations, Manufacturing, and Engineering to initiate corrective actions or work orders when issues are identified. The role requires a clean and safe work environment and may include serving as a mentor to Quality Lab Technician positions. The listed schedule is 12 p.m. to 12 a.m.; overtime is worked as required.

Requirements

Bachelor of Science degree in Microbiology, Biology, or a related science.
Strong communication and project management skills.
Knowledge of core manufacturing and support systems.
Computer literacy, including Microsoft Office applications such as Word and Excel.
Good interpersonal skills and ability to work effectively and efficiently in a team-based environment.
Proficiency in the aseptic use and handling of media plates and swabs for environmental monitoring sampling.
Ability to work with minimal direction.
Attention to detail and strong organizational skills.
Basic understanding of laboratory instrumentation.
Good documentation skills and knowledge of Good Documentation Practices (GDPs).
Ability to manage multiple tasks and priorities in a timely manner.
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLP, and USP testing methodology.
Authorization to work for an employer in the United States; visa sponsorship or transfer is not available.

Nice To Haves

At least one year of experience in the pharmaceutical or medical device industry.
Familiarity with LIMS or an equivalent system and TrackWise.
Knowledge of FDA quality system regulations.

Responsibilities

Support the environmental monitoring program through surface testing, viable air monitoring, and air total particle counts.
Conduct microbiological analyses on raw materials, in-process materials, and finished products.
Use laboratory instrumentation and computer systems to collect and record data.
Complete routine and special-project or protocol testing in a timely manner according to local procedures and cGMP regulations.
Maintain data integrity and ensure compliance with regulatory agencies.
Operate equipment such as SAS Air Samplers and Climet Particle Counters to collect air and particulate samples.
Perform surface sample testing using plate and/or swab methods.
Collect water samples throughout the facility on a weekly or monthly basis.
Perform weekly and monthly HEPA inspections to verify filter integrity in clean rooms.
Perform weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms.
Perform Instantaneous Microbial Detection (IMD) testing.
Review environmental events and deviations to ensure documentation and testing are complete before submission for approval.
Work with Quality Operations, Manufacturing, and Engineering to initiate corrective actions or work orders when issues are identified on the floor.
Maintain a clean and safe work environment using 6S principles.
Serve as a mentor to Quality Lab Technician positions.

Benefits

Medical, dental, and vision coverage starting on day one.
Paid time off and paid holidays.
401(k) retirement savings plan with company matching.
Employee Stock Purchase Plan, including the ability to purchase company stock at a discount.
Paid parental leave.
Tuition reimbursement and educational assistance programs.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
Flexible Spending Accounts.
Family and medical leaves of absence.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.