Quality Control Manager

The QC manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 GMP operations to ensure compliance with regulatory requirements and managing the quality control functional group. The QC manager will interact with customers to respond to their question/concerns/needs of analytical services including but not limited to stability studies, method development and/or transfer. The Quality Control team is responsible for all analytical activities associated with the support of manufacturing activities, including raw material testing. The QC manager is responsible to foresee the QC workload; trend and plan adequately in response to the increasing demand for QC services.

 

The QC manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 GMP operations to ensure compliance with regulatory requirements and managing the quality control functional group

 

Responsibilities

  • Maintain, supervise and participate in the daily activities of the QC laboratory by establishing testing priorities and scheduling of staff in coordination with company goals/priorities
  • Perform and assist with laboratory investigations and other quality events
  • Provide daily guidance, mentoring, and feedback to staff
  • Oversee and participate in product testing to identify any deviations/out of specifications
  • Ensure QC equipment calibrations and maintenance are completed as scheduled
  • Review laboratory notebooks, raw data, reports, protocols, etc., as necessary
  • Author/review QC analytical SOPs, protocols, etc
  • Perform change controls to update current analytical GMP documents
  • Ensure QC laboratory compliance and audit-readiness with applicable regulations
  • Author/review method validation protocols/reports
  • Oversee/perform method development/validation/ verification activities for API and drug products
  • Supervise procedural, cGMP, and safety training of laboratory staff
  • In coordination with QA, ensure QC activities adhere to cGMP regulations and any other regulatory guidelines
  • Assist with preparations for internal and external laboratory audits and inspections
  • Ensure the Safety Guidelines set forth by the company are followed in the QC lab
  • Other related duties as required

 

Successful applicant will demonstrate:

  • Superior reasoning and problem-solving skills with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
  • Excellent interpersonal, communication and writing skills.
  • Ability to effectively present information and respond to questions from management, peers, and external personnel. Attention to detail in communication with management as well as staff is essential.
  • Aptitude at identifying prospective problem areas and recommending process improvements.
  • Ability to manage multiple tasks, meet deadlines, and work under pressure in a fast-paced environment with attention to detail.
  • High level of integrity and dependability with a strong sense of urgency and results-orientation.
  • Fundamental understanding of the drug development process, scientific methods and thought.
  • Thorough knowledge of FDA requirements pertaining to the quality control in CFRs for pharmaceutical manufacturing. Experience in device quality control is additionally preferred.
  • Ability to carefully proofread reports and determine appropriate action.
  • Computer skills necessary to maintain integrated quality system. Extensive word processing and data entry work on computers will be involved.

 

REQUIREMENTS:

  • Bachelor’s degree and > 5 years industry experience or PhD with > 2 years industry experience in Chemistry, polymer chemistry/physics or related discipline
  • 5 years’ experience (2 years in a supervisory role) in a QC or analytical chemistry laboratory
  • Understanding of FDA regulations (21 CFR 58, 210, 211, etc.) and USP
  • In depth knowledge of analytical testing of raw materials, in-process samples, finished products and analytical laboratory instrumentation, such as HPLC, GC, FTIR, TOC, NMR, dissolution apparatus, etc. SEC-MALS experience is preferred.
  • Strong investigational skills to determine root cause and identify effective corrective actions
  • Strong communication and listening skills, with excellent observational, analytical, and problem-solving skills
  • Knowledgeable with regulatory compliance and skilled in understanding/ interpreting scientific and technical data
  • Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision
  • Experience with analytical methods development and validation
  • Experience with equipment calibrations, maintenance and qualifications
  • Proven ability to lead, coach, and motivate employees

Diversity is important at Synedgen. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

Submit full resume, cover letter and contact information for three references to careers@synedgen.com. Applications without a cover letter will not be reviewed.

 

Manager, Quality Assurance & Compliance

Synedgen is seeking a talented Manager of Quality Assurance with expertise in CMC and early stage (pre-IND and early clinical) compliance with a minimum 5 years’ experience working in Quality Assurance in a Pharmaceutical FDA regulated industry. The Quality Manager must be adept at working both independently and collaboratively with other business verticals, including manufacturing, QC, CMC regulatory, Contract Research Organizations and management. The ideal candidate will have experience in Quality System Development, CMC conformance, Gap analysis and Remediation, together with a solid knowledge of relevant regulatory agency guidance including ICH and FDA. The QA Manger is responsible for overall management of Quality Assurance operations and assures all applicable regulations are followed.

Roles & Responsibilities

  • Author and review procedures, specifications, quality reports, and other quality documents, customized to different client business processes and requirements.
  • Participate or lead as appropriate meeting with QA, QC and manufacturing teams and reporting to management.
  • Provide QA support and assistance for facilities, utilities, and equipment; review and disposition Out-of-Tolerance records for equipment; review technical, investigation, validation/ qualification documentation related to Production with appropriate audit trail.
  • Manage data integrity practices/ requirements in Production as established by Synedgen Policies, site procedures and regulations.
  • Oversee timely initiation of deviations and investigations related to Production; assure investigations are completed in satisfactory manner and in accordance with the level/ classification of discrepancy.
  • Lead initiation, evaluation and completion of Change Controls related to Production.
  • Propose Corrective and Preventive Actions for continuous improvement of system and activities in Production; ensure all associated CAPAs are implemented according to the established procedures and policies.
  • Provide information for Product Quality Reviews and participate in review/approval of PQRs.
  • Participate in and support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
  • Support Management during regulatory agency inspections and audits
  • Work collaboratively to optimize appropriate Quality systems for Synedgen’s pre-clinical programs and to and implement phase appropriate systems.
  • Act as a subject matter expert on quality issues and compliance-related matters for manufacturing, packaging and distribution to CRO’s.
  • Conduct Quality audits for incoming materials and CRO’s.
  • Achieve and maintain appropriate gowning requirements to provide QA on-the-floor oversight, line clearance and other QA functions in Production area.
  • Ensure process control measures are in place and followed in product manufacturing.
  • Perform QA review and approval of Master Batch Records, forms, procedures, test methods and other master documents related to Production.
  • Manage and ensure that deviations, discrepancies, change controls, etc. related to Production are resolved and closed prior to batch release.
  • Direct timely issuance of production records, procedures and other documentation.

Qualifications & Education Requirements

  • BS/MS in the life sciences or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
  • 5+ years of experience in CMC Quality Assurance in the pharma or biotech industry.
  • 3 + years of personnel supervisor / manager experience.
  • Understanding of Quality system reviews, deviations, OOS, CAPAs, and other remediation plans
  • Comprehensive understanding of CFR regulations (21CFR Part 210, 211 etc), ICH guidelines, quality management systems initiatives, and standards.
  • Working knowledge and ability to apply GMPs in conformance to U.S. standards and exposure to CMC/Pharma Development and development teams.
  • Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
  • Experience performing GMP audits of manufacturing facilities of vendors and internal operations.
  • Understanding of computer systems validation methodologies and related industry expectations.

Required Personal Skills

  • Enthusiasm to help build the assets of a small, growing pharmaceutical company
  • Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for Batch Record, Quality Management Systems, is a plus.
  • Excellent team-building, leadership, and management skills.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Strong problem solving/process improvement skills with ability to both be a part of and own solutions.
  • Adept at applying risk-based and phase-appropriate quality approaches.
  • Strong attention to detail and the ability to independently prioritize and multitask.

Applicants should provide a resume, a cover letter and 3 references. Applications without a cover letter will not be considered.

This position is full-time at the facility and is not eligible for remote work. Modest relocation expenses will be considered for exceptional candidates.

Synedgen is an equal opportunity employer. All qualified applicants will receive consideration for employment and advancement without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.