QC Supervisor in Wayne, PA at Apex Life Sciences

Date Posted: 9/14/2018

Job Snapshot

Job Description


JOB PURPOSE & SUMMARY OF POSITION

The QC Supervisor is responsible for managing QC team ensuring staff development, timely support for manufacturing and GMP compliance. Provides guidance on procedures to ensure continuous improvement in customer satisfaction, related regulatory compliance, and operational safety and efficiency of the group. Oversees QC projects ensuring timely completion with quality, and within the budget.  Provides leadership to the group through effective communication, coaching, training, development, and ensures staff acts in accordance with Johnson Matthey policies and practices with respect to GMP, safety, and other related regulatory requirements.

PRINCIPAL ACCOUNTABILITIES

  • Oversees and directs the work of Quality Control Chemist who perform testing of raw materials, intermediates, and APIs in support of process development and manufacturing.
  • Conducts QC testing as required.
  • Interact with production (kilo laboratories and/or plant) Manager to assess Quality Control support needs and coordinates coverage for all shifts, assigns projects/ responsibilities, delegates analyses (as needed), reviews data.
  • Supervises of QC personnel (including hiring decisions, evaluations of performance, and identification of training and development needs).
  • Participates in deviation and OOS investigations.
  • Develops, improves, and revises SOPs, test methods, and other GMP documentation as needed.
  • Assures compliance of laboratory operations and contributes to laboratory organization including calibration, qualification and re-qualification of instruments.
  • Leads knowledge transfer for analytical procedures from the Analytical Development group.
  • Identifies and leads continuous improvement initiatives.
  • Communicates with internal and external clients.
  • Actively participates in quality and safety audits and walkthroughs.
  • Directs and advises the Quality Control group to achieve long and short term goals and objectives.
  • Provides guidance and direction to other Johnson Matthey Pharma Services (JMPS) staff in order to implement the quality vision for both JMPS sites.
  • Provides support to JM locations as needed or directed by the manager.
  • Others duties as assigned

QUALITY/REGULATORY RESPONSIBILITIES

  • Manages staff in full compliance with cGMP requirements.
  • Responsible for departmental audit readiness and for participating in quality audits with FDA and customers.
  • Ensures staff acts in accordance with Johnson Matthey quality policies and practices with respect to cGMP and other related requirements.
  • Manages compliance with state and federal regulations, including but not limited to GMP, DEA, and FDA.
  • Implements and applies cGMP concepts in association with department specific responsibilities.
  • Demonstrates technical expertise and self-assuredness in applying cGMP standards.

ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES

  • Manages staff in full compliance with all appropriate EH&S policies and procedures.
  • Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers.
  • Ensures staff acts in accordance with EH&S policies, practices and procedures.
  • Addresses staff issues accordingly if there are EH&S violations.
  • Actively participates in root cause investigations on near misses and all incidents.  Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department.
  • Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc.
  • Implements, applies and places emphasis on EH&S concepts with department specific responsibilities.
  • Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.
  • Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities.

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
  • Must be able to lift and/or move up to 50 pounds using available material handling equipment.
  • Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
  • Regularly works with moving mechanical parts and may work with toxic or caustic chemicals.  The work may be performed in humid areas with low or high temperatures.

QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE

ESSENTIAL

  • BS in Chemistry or equivalent with 7-8 years experience in Analytical and Quality Control in an API development and manufacture industry.
  • MS in Chemistry or equivalent with 5-6 years experience in Analytical and Quality Control in an API development and manufacture industry.
  • Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly
  • Excellent analytical, written and verbal communication skills
  • Strong technical writing skills and the ability to clearly express ideas in English
  • Knowledge and previous experience with GMP, ICH Q7
  • Extensive knowledge in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
  • Knowledge in organic chemistry
  • Experience supervising and/or managing staff members in a Quality department.
  • Ability to work independently and in a team environment
  • Ability to positively resolve conflict
  • Experience with Microsoft Office and other complex computer software (Trackwise® and Empower)

VALUED

  • Experience with a range of organic analytical chemistry techniques with particular emphasis on chromatographic methods. (HPLC, GC, Ion Chromatography, LC-MS)
  • Experience with titrations, KF, NMR, UV-VIS, FTIR, DSC and TGA

Please reply with your most recent resume to grucci@apexlifesciences.com today!

LI-GR1

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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