... control, complaints resolution), host FDA inspections and respond to questions arising from the ... in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing ...
... control, complaints resolution), host FDA inspections and respond to questions arising from the ... in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing ...
... control, complaints resolution), host FDA inspections and respond to questions arising from the ... in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing ...
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... control, complaints resolution), host FDA inspections and respond to questions arising from the ... in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing ...
The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
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The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and ... or Biotechnology or related field. * Minimum 2 - 5 years of experience in using analytical ...
Research Associate
Charlottesville, VA · On-site
... quality control, membrane biology, and proteostasis in physiology and disease ( ). Using a ... biotechnology. The laboratory is located within the Fontaine Research Park at the University of ...
Research Associate
Charlottesville, VA · On-site
... quality control, membrane biology, and proteostasis in physiology and disease ( ). Using a ... biotechnology. The laboratory is located within the Fontaine Research Park at the University of ...
Minimum of 5 years' experience in validation (with Bachelors degree) or 4 years (with a Masters degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or ...
Minimum of 5 years' experience in validation (with Bachelors degree) or 4 years (with a Masters degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or ...
Director - Life Sciences Advisory - Commercial
$206K - $343K/yr
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
Director - Life Sciences Advisory - Commercial
$206K - $343K/yr
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
Associate Director - Life Sciences Advisory - Patient Support Programs (Pharma)
Arlington, VA · On-site
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
Associate Director - Life Sciences Advisory - Patient Support Programs (Pharma)
Arlington, VA · On-site
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
... quality control and key client's perceived value while supervising, mentoring and developing ... Biotech, Specialty Pharma and/or Medical Technology) consulting experience or blend of consulting ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
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... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
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... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
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... biotech, mission-critical, and other regulated industries. With headquarters in Lenexa, Kansas and ... Perform quality control reviews of design documents and field work. * Develop and evaluate project ...
The National Center for Biotechnology Information (NCBI) is part of the National Library of ... Experience with version control systems like Git or SVN * Excellent verbal and written ...
The National Center for Biotechnology Information (NCBI) is part of the National Library of ... Experience with version control systems like Git or SVN * Excellent verbal and written ...
Biotechnician I (Hopewell, NJ)
$25.48 - $33.48/hr
Change control drafting, presenting, closure * cGMP procedure development and optimization ... Performing in-process visual inspection for quality assurance * Labeling and packaging of finished ...
Biotechnician I (Hopewell, NJ)
$25.48 - $33.48/hr
Change control drafting, presenting, closure * cGMP procedure development and optimization ... Performing in-process visual inspection for quality assurance * Labeling and packaging of finished ...
Mechanical/HVAC Engineer
Reston, VA · On-site
$88K - $118K/yr
The ideal candidate brings a strong understanding of cGMP environments, contamination control ... quality assurance, automation and manufacturing teams Perform root cause investigations and ...
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Mechanical/HVAC Engineer
Reston, VA · On-site
$88K - $118K/yr
The ideal candidate brings a strong understanding of cGMP environments, contamination control ... quality assurance, automation and manufacturing teams Perform root cause investigations and ...
Sr. Validation Manager
Petersburg, VA · On-site
Process automation and control systems * Establish and implement cleaning validation requirements ... Coordinate with Engineering, Quality, Manufacturing, and external vendors. Validation Lifecycle ...
Sr. Validation Manager
Petersburg, VA · On-site
Process automation and control systems * Establish and implement cleaning validation requirements ... Coordinate with Engineering, Quality, Manufacturing, and external vendors. Validation Lifecycle ...
About the job At Afton Scientific, every role contributes to advancing the quality and reliability ... Control, and/or SAP. • Experience with cleanroom operations and environmental monitoring • ...
About the job At Afton Scientific, every role contributes to advancing the quality and reliability ... Control, and/or SAP. • Experience with cleanroom operations and environmental monitoring • ...
Biotech Quality Control information
See Virginia salary details
$30.2K - $39.2K
5% of jobs
$39.2K - $48.1K
5% of jobs
$48.1K - $57K
11% of jobs
$59.8K is the 25th percentile. Wages below this are outliers.
$57K - $65.9K
13% of jobs
$65.9K - $74.9K
14% of jobs
The median wage is $76.9K / yr.
$74.9K - $83.8K
12% of jobs
$83.8K - $92.7K
13% of jobs
$95.6K is the 75th percentile. Wages above this are outliers.
$92.7K - $101.6K
11% of jobs
$101.6K - $110.5K
7% of jobs
$110.5K - $119.5K
5% of jobs
$119.5K - $128.4K
5% of jobs
$30.2K
$80.6K
$128.4K
How much do biotech quality control jobs pay per year?
What are the typical daily responsibilities of someone working in Biotech Quality Control?
On a daily basis, a Biotech Quality Control professional performs routine testing and analysis of raw materials, intermediates, and finished products to ensure they meet established specifications. This involves preparing samples, operating analytical equipment, maintaining accurate records, and documenting results in compliance with regulatory guidelines. Quality Control staff also collaborate closely with production, quality assurance, and research teams to troubleshoot issues and support process improvements. Regular internal audits and participation in team meetings are common, making communication and teamwork key parts of the job.
What is a Biotech Quality Control job?
A Biotech Quality Control (QC) job involves ensuring that biological products, processes, and facilities meet regulatory and quality standards. QC professionals conduct testing, analyze data, and document results to verify product safety and efficacy. They work with laboratory techniques such as PCR, HPLC, and microbiological testing. The role is critical in maintaining compliance with industry regulations like GMP and FDA guidelines.
What are the key skills and qualifications needed to thrive in the Biotech Quality Control position, and why are they important?
To excel in Biotech Quality Control, candidates typically need a background in biology, chemistry, or related sciences, with strong knowledge of laboratory techniques and regulatory requirements. Familiarity with laboratory information management systems (LIMS), Good Manufacturing Practices (GMP), and common analytical instruments such as HPLC or PCR is highly valued. Attention to detail, problem-solving abilities, and effective communication are crucial soft skills for this role. These competencies are vital for ensuring that biotech products consistently meet quality and compliance standards essential for patient safety and regulatory approval.

Full-time
Posted 6 days ago
Job description
Full-time
Description
**US Based Candidates Only**
Granules Pharmaceuticals, Inc., located in Chantilly, VA was the 10th fastest growing generic pharma company in United States in 2024 based on sales growth! We manufacture dosage forms with specific release capabilities including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform, all supported by our API business. Granules is one of the few pharmaceutical companies to be vertically integrated from API to packaging.
As a Director, QA Compliance, you will be accountable for the leadership activities and to direct all facets of Quality Compliance including, but not limited to, managing Quality Systems (incidents resolution, CAPAs, change control, complaints resolution), host FDA inspections and respond to questions arising from the inspections, oversee remediation activities for site-wide compliance improvements, external and internal audits, training with effectiveness checks, Quality metrics, data trending and evaluation with recommendations for cGMP Compliance improvements. Additionaly, you will ensure sustainable cGMP compliance, participate with regulatory bodies to address questions, and act as the lead for drafting responses to FDA Form 483 observations.
The Director, QA Compliance, will provide regular monthly updates to senior management regarding the progress and status of cGMP Compliance.
This is an on-site position.
- Provide leadership and direction regarding cGMP Compliance at the Chantilly site to ensure adherence to applicable Regulations.
- Excellent knowledge of the 21CFR, ICH, and USP to interpret and apply Regulations with respect to any questions related to cGMP Operations at the Chantilly site.
- Represents the department during high level discussions and investigations with external customers, vendors, and FDA representatives.
- Lead as the site Quality representative during FDA inspections.
- Lead the site in inspections conducted by external regulators and business partners.
- Conduct Compliance GAP analysis with recommendations for gap closure, implementation and follow up of effectiveness checks.
- Implement and follow through with site-wide remediation and improvement plans based on assessment of Quality metrics.
- Maintain Quality metrics for the site with analysis of data to sustain Compliance at the site.
- Responsible for building effective systems, processes and cross-functional teams to manage Compliance at the site.
- Manage and develop direct reports by setting clear expectations and resolving conflicts.
- Responsible to ensure adherence to company protocols and close in a timely manner any deviations from procedures or cGMP requirements.
- Interface with different departments regarding quality issues, audits and special projects.
- Provide guidance to manufacturing regarding Quality cGMP issues to ensure compliance with applicable standards and regulations.
- Provide technical expertise for personnel training, deviations, CAPA, inventory management, cGMP compliance and data trending.
- Review and approve, as required, OOS, SOPs, protocols and investigations.
- Coordinate and supervise the collection of data reported in the product review.
- Prepare, as required, and review documentation required for regulatory submissions.
- Serve on the Quality Task Force and participate in the generation and review of company standard operating procedures.
- Ensure the site remains current with all changes to applicable compendia, regulations and guidance.
- Manage direct reports, Responsibility includes training and developing direct reports to keep abreast of current technology as it relates to cGMP Compliance.
Requirements
Reports to
Global Quality Head
Minimum Experience & Education
- BA/BS in Biochemistry, Chemistry or related field, MS/MA preferable
- 13 + years of experience in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing highly preferred
- 5+ years experience in leadership position within Quality
Required Knowledge & Skills
- Knowledge of 21CFR, ICH, USP and other applicable regulatory requirements and standards.
- Manage and host Regulatory inspections.
- Ability to maintain integrity and honesty at all times.
- Ability to communicate and lead with transparency.
- Lead department for optimal performance and set course for future improvements.
- Accountable for performance and results of department.
- Management experience required
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.