Senior Associate, Quality Control QCM
About The Position
The Quality Control Senior Associate will support the facility environmental and utility monitoring (EM) programs in support of sterile product manufacturing, to include sampling, testing, and data management of the collected samples, training personnel on aseptic technique and aseptic gowning, complete investigations, and support lab operations such as equipment preventive maintenance, supply inventory management, and general support tasks in order to allow the lab to continuously operate. The position will also provide leadership and guidance to junior analysts, support method/SOP revisions, study protocols, method transfers, and qualifications. The incumbent may also support lab assays for lot release and stability testing, participate in sample preparation and aliquoting, media lot release testing.
Requirements
- Bachelor’s degree in a life sciences discipline with 2-4 years of experience in a GMP regulated Biologics or Pharmaceutical environment.
- Knowledge of regulatory expectations for QC Microbiology department
- Knowledge of environmental and critical utilities monitoring, personnel monitoring, aseptic processing, and microbiological testing assays.
- Fundamental knowledge of microbiology (knowledge of cell and molecular biology, immunology, and virology is a plus).
- Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
- Strong problem-solving skills with demonstrated attention to detail.
- Good understanding and demonstration of aseptic techniques.
- Proficient in Microsoft Word, Project, and Excel
- Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity.
- Strong verbal, written, and interpersonal communication skills.
- Proficiency in computer use and Microsoft Office applications.
- Proven ability to work independently and analyze and resolve issues that impact quality.
- Attention to detail with strong analytical and problem solving skills.
- Well-developed written and oral communication skills; motivated to work in a team environment.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
- Exceptional organization and time-management skills.
- Ability to deliver under deadlines.
- Ability to multi-task and retain flexibility in a dynamic environment.
- Consistently deliver on commitments
Nice To Haves
- Experience in cGMP aseptic processing facility is a plus
Responsibilities
- Organize daily workload schedule and relevant resource requirements.
- Participate in authoring complex, explicit documentation for manufacturing operations.
- Environmental and Critical Systems monitoring, testing, review, reporting, and trending.
- Reviewing of data, trending, and applicable investigations.
- Support all compliance aspect related to microbiological and analytical testing and will support investigations and root cause analysis.
- Play a critical role in working collaboratively with manufacturing technicians and associates in support of EM.
- Routine and validation sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method or equipment qualification/validations.
- Responsible for laboratory maintenance to include cleaning and sanitization of laboratory equipment, laboratory restocking of supplies and inventory.
- Coordinate and generate Risk Assessments.
- Assist with the drafting of controlled documents including Protocols, Reports, SOPs, Test Methods, Specifications and Work Instructions, data entry and reporting
- Perform other duties as assigned.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
