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Form of workSummary:
The Quality Control (QC) Specialist is responsible for coordinating and assisting with tasks associated with maintaining a quality management system, including analyzing materials using various instrumental and analytical techniques; performing qualification, verification, and validation activities; and maintaining and reviewing cGXP records.
Essential Duties and Responsibilities: *
This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.
The key duties and responsibilities for this position are as follows:
- Maintain and operate laboratory equipment in a safe and efficient manner, including coordinating and conducting preventative maintenance, cleaning, calibration, and qualification activities.
- Perform inspection of incoming material based on material specification of established documents.
- Sample preparation and analysis according to USP and Lumen methods utilizing various biochemical techniques.
- Coordinate sample analysis with on-site staff and third-party labs for stability, routine, qualification, verification, and validation activities
- Route material to testing labs and follow up thoroughly and timely to release material for production.
- Participate in production activities to ensure requested QC testing is on-time, accurate and documented.
- Maintain accurate records of activities in a timely manner.
- Create, review, and edit procedures to contribute to continuous improvements in safety, quality, and efficiency.
- Assist with preparation and execution of internal and 3rd party audits and other reviews
- Document QC activities using cGMP and record results Benchling or other QMS/LIMS based systems.
- Identify nonconformance, initiate report, and perform investigation as needed.
- Assure frequent revision of documents for accurate documentation of current material specifications and requirements.
- Evaluate assay results for validity and acceptability in support of manufacturing for in-process materials, finished goods and stability monitoring.
- Perform data reviewing, archiving duties, which support investigations, improvement projects, tracking of manufacturing and trending of results.
- Collaborate with R&D for new assays development, author and execute new assay verification, and validation protocols and reports.
- Perform equipment calibrations and maintenance in support of QC laboratory.
*This job description is not designed to cover or contain a comprehensive listing of duties, activities, or responsibilities that are required of the employee. Other duties responsibilities, and activities may change or be assigned at any time with or without notice
Desired Qualifications & Requirements:
Education and Experience:
- Minimum 10 years of work experience in Quality Control in a regulated (cGXP) organization
- -OR- a PhD in biochemistry, microbiology, or related scientific field plus 3 years of work experience in Quality Control
- -OR-a bachelor's or master's degree in biochemistry, microbiology or related scientific field plus 5 years of work experience in Quality Control
- Thorough knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records
- Solid understanding of various biochemical assays such as ELISA, Enzymatic assay, dPCR, NGS, and microbiologic tests.
- Demonstrated critical thinking skill and ability to perform trouble shoot activity.
- Demonstrated technical aptitude and experience with pharmaceutical tech transfer including analytical methods verification, and validation that are suitable for different phases of FDA clinical trial phase requirements.
- Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.
- Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.
- Capable of supporting multiple projects simultaneously in a deadline-driven environment
- Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment.
- High level of proficiency in Microsoft Word, Excel, Powder point, and SharePoint.
- High integrity and ethics
- Commitment to quality and timely delivery of results
Physical Requirements:
- Sit for extended periods of time (2 or more hours)
- Standing for extended periods of time (2 or more hours)
- Occasionally lift or carry up to 20 kg
The salary range for this role is $70,000 to $85,000.
Employment Type: Full-Time
