QA/QC Manager

Newark, NJ

Posted: 02/27/2019 Industry: Laboratory - Industrial Chemicals Job Number: 70.19LR Pay Rate: 90,000 - 150,000

QA/QC Manager

Ensure the development, implementation and review of Quality Systems so that they are adequate and compliant.  Responsible for oversight of daily activities, including:  Major projects, QA team support; validation activities; Regulatory inspections, Change Control, KPIs and Events Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Updated Quality system SOPs as necessary
  • Review/comment on all site SOPs
  • Review all production batch records
  • Review/approve change controls – communicating changes to customers and getting their approval
  • Review/approve equipment qualifications
  • Review/approve process validation
  • Review/approve cleaning validations
  • Manage the internal audit program
  • Manage the stability program
  • Maintain the FDA/DEA licenses
  • Create Quality Agreements between company and all suppliers/contractors/customers
  • Host external audits
  • Review/approve investigations/OOS
  • Conduct supplier qualifications
  • Manage the Corrective and Preventative Action (CAPA) program
  • Conduct external audits as necessary
  • Manage the complaint program
  • Update and maintain DEA ARCOS/inventory reports
  • Maintain a compliant DEA program
  • Oversee training programs (safety, GMP, procedural, etc.) and conduct necessary training
  • Create annual product review for all products
  • Assist in destruction of controlled substance
  • Spend time in t he production area proactively identifying issues
  • Manage subordinate staff. Perform supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.  The QA/QC Manager will supervise 2 QA people and 1 QC Manager with 2 QC Chemists

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / larry@cps4jobs.com.

JO:  70.19LR
#LI-LR1

Requirements:

  • A Bachelor’s degree in related field (Science or Engineering)
  • Five to seven years recent related experience is required
  • Experience in an API manufacturing environment is a plus
  • Should have FDA Audit experience
  • Must be hands-on
  • Must be a team player with good oral and written communication skills
  • Must be a strong supervisor

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Larry Riederer at 815.756.1221 / larry@cps4jobs.com.

JO:  70.19LR
#LI-LR1

Larry Riederer
Market Specialist

I have over 20 years of experience with Chemical Personnel Search (CPS) . All we do is recruit and place people in the chemical industry nationwide. CPS has been recruiting chemists, engineers, sales people and supply chain since 1973. I work with 40 other recruiters. 


I have a wide range of positions and levels.
The following are some of the areas: Polymers, Resins, Coatings, Adhesives, Inks, Composites, Plastics, Lubricants, Personal Care, Skin/Hair Care, Cleaners and Specialty Chemicals.

These can be: Organic/Polymer Synthesis, New Product Development, Analytical/Characterization, Quality Control, Process Development, Materials Science and others. These are from BS to Ph.D. and from Entry Level to Vice-President. 

Specialties: We specialize in placing Chemists, Scientists and Managers in the industrial chemical industry

 

For more information please reach out!

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