Job Description:
Primary responsibilities for this position include performing tasks associated with critical testing on raw materials, environment, utilities, validation samples, and manufactured materials. The analyst will be responsible for ensuring that client QC Microbiology samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.
Responsibilities:
Performs testing and associated tasks without errors per applicable SOPs and protocols.
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Develops and maintains SOPs
Develops expertise in assigned assays/techniques
Authors lab investigation and invalid assay assessments
May be required to perform shift work as required to support the operations
Skills:
3+ years of laboratory experience OR equivalent preferred.
Intermediate knowledge of GMPs, safety regulations and data integrity
Intermediate knowledge of analytical methods and related instrumentation.
LIMS experience preferred
Experience performing Environmental Monitoring within a pharmaceutical environment
Experience performing Bioburden, Endotoxin, and Sterility.
Qualifications:
Bachelor s degree in Scientific discipline and 3+ years experience or associate s and 5+ years of industry experience or equivalent
Experience with environmental monitoring in manufacturing areas
Some experience with working in an analytical testing lab (academic or industry)
Desired Requirements (Nice to Have):
Experience working in a cGMP Pharmaceutical Laboratory
Experience with Laboratory Information Management Systems (LIMS)
Experience performing Bioburden, Endotoxin, and Sterility
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.