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Contract Pharmaceutical Quality Control Jobs (NOW HIRING)

Amneal Pharmaceuticals

Manager, QC Lab

Piscataway, NJ · On-site

Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.

Alexza

Lead QC Analyst, QC Operations

Fremont, CA · On-site

$121K/yr

Bachelor's Degree in science or related field * 8+ years relevant experience in a cGMP pharmaceutical QC environment or 5+ years with a Master's degree Physical Requirements * Prolonged periods of ...

Amneal Pharmaceuticals

Manager, QC Lab

Piscataway, NJ · On-site

Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.

Amneal Pharmaceuticals

Manager, QC Lab

Piscataway, NJ · On-site

Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.

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Contract Pharmaceutical Quality Control information

What are the key skills and qualifications needed to thrive as a Contract Pharmaceutical Quality Control specialist, and why are they important?

To thrive as a Contract Pharmaceutical Quality Control specialist, you need a strong background in chemistry, biology, or a related field, with experience in laboratory testing and quality assurance processes. Familiarity with analytical instruments such as HPLC, GC, and LIMS, as well as knowledge of regulatory standards like GMP and relevant certifications, is typically required. Attention to detail, problem-solving abilities, and strong communication skills are essential for accurate testing and effective collaboration. These skills and qualities ensure product safety, regulatory compliance, and the reliability of pharmaceutical products in a highly regulated industry.

What is the difference between Contract Pharmaceutical Quality Control vs Contract Pharmaceutical Quality Assurance?

AspectContract Pharmaceutical Quality ControlContract Pharmaceutical Quality Assurance
Primary FocusTesting and analyzing drug samples to ensure quality and complianceDeveloping, implementing, and maintaining quality systems and procedures
Work EnvironmentLaboratories, testing facilities, manufacturing sitesOffice settings, quality management departments, regulatory agencies
Required CredentialsDegree in pharmacy, chemistry, or related field; certifications in lab testingDegree in pharmacy, chemistry, or related field; certifications in quality systems
Industry UsageUsed by pharmaceutical companies during product testing phasesUsed for ensuring overall quality compliance and regulatory adherence

Contract Pharmaceutical Quality Control focuses on testing and analyzing pharmaceutical products to verify quality, while Contract Pharmaceutical Quality Assurance emphasizes establishing and maintaining quality systems to ensure compliance. Both roles are essential in the pharmaceutical industry but serve different functions within the quality management process.

What is Contract Pharmaceutical Quality Control?

Contract Pharmaceutical Quality Control refers to the process where pharmaceutical companies outsource the testing and analysis of their products to third-party laboratories or service providers. These contract labs ensure that drug products meet regulatory standards for safety, efficacy, and quality before they reach the market. Services often include analytical testing, microbiological testing, method development, and stability studies. By outsourcing this work, companies can access specialized expertise and equipment, streamline operations, and maintain compliance with global regulations.

What are some common challenges faced in a Contract Pharmaceutical Quality Control role and how can they be effectively managed?

In a Contract Pharmaceutical Quality Control role, professionals often navigate challenges such as tight project deadlines, varying client expectations, and strict regulatory requirements. Managing these challenges effectively involves clear communication with clients, thorough documentation, and staying updated with industry standards like GMP and FDA guidelines. Team collaboration is key, as projects typically involve coordination with analytical chemists, quality assurance specialists, and production staff. Adaptability and attention to detail are essential for ensuring both compliance and client satisfaction in a fast-paced, contract-based environment.
What cities are hiring for Contract Pharmaceutical Quality Control jobs? Cities with the most Contract Pharmaceutical Quality Control job openings:
What are the most commonly searched types of Pharmaceutical Quality Control jobs? The most popular types of Pharmaceutical Quality Control jobs are:
What states have the most Contract Pharmaceutical Quality Control jobs? States with the most job openings for Contract Pharmaceutical Quality Control jobs include:
Contract Pharmaceutical Quality Control jobs near you
Lead QC Analyst, QC Operations

Lead QC Analyst, QC Operations

Alexza Pharmaceuticals

Fremont, CA

$121K/yr

Full-time

Posted 19 days ago

Job description

Job Summary

Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Proactively identifies gaps, takes ownership of problems beyond the immediate scope of assigned tasks, and drives initiatives to completion with minimal direction. Demonstrates the confidence and sound judgment to make decisions independently and to lead cross-functional efforts when required.

Responsibilities

  • Provide timely analyses to support manufacturing and stability, assuring that deadlines are met, maintaining data integrity and ensuring compliance with company SOPs and specifications
  • Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working Identify and implement appropriate instrumentation or techniques. Provide training to junior analysts on instrumentation, techniques, and test methods
  • Revise and create standard operating procedures (SOPs), author and review technical Implement QC protocols and SOPs with training provided to junior analysts for execution.
  • Conduct lab investigations and independently lead the development and implementation of corrective actions and improvements
  • Function as QC SME for select test methods and equipment to support method validations, serve as point of contact for service providers during routine PM/CAL and repair of equipment
  • Uphold QC compliance by supporting QC document revisions, data review, laboratory housekeeping, equipment PM/CAL review, equipment and supplier assessments, as needed
  • Take initiative to identify process gaps, propose solutions, and drive improvements proactively - without waiting to be directed - escalating risks and decisions appropriately while maintaining accountability for outcomes
  • Other duties as assigned

Skills required

  • Demonstrated ability to work independently and exercise sound judgment; self-directed, takes initiative, and is comfortable owning decisions and outcomes without close supervision
  • Well-organized, capable of multi-tasking, strong interpersonal skills in order to collaborate with individuals in a matrix environment
  • Expertise in performing relevant analytical techniques (HPLC, GC, FTIR).
  • Extensive experience with EMPOWER with excellent data analysis skills and attention to detail and interpretation of results
  • Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL,
  • Excellent knowledge of method validation, transfer requirements, and laboratory investigations
  • Proven track record of leading projects or initiatives, with the confidence to set priorities, rally stakeholders, and see work through from conception to completion

Education and experience

  • Bachelor's Degree in science or related field
  • 8+ years relevant experience in a cGMP pharmaceutical QC environment or 5+ years with a Master's degree

 Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • Potentially prolonged periods standing
  • Must be able to lift up to 15 pounds at times
  • Must be willing to travel

Compensation

The base salary for this role starts at $121,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.

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