GC Specialists- Quality Control

 

ESSENTIAL FUNCTIONS:

  1. Prepare samples for analysis, analyze, and report results.
  2. Prepare controlled documentation in support of the sampling, analysis, and reporting of results. 
  3. Analyze data with respect to standards or to previously determined parameters.
  4. Perform routine review in support of GMP.
  5. Perform testing of raw materials according to PPL-SD procedures.
  6. Perform API testing according to PPL-SD procedures.
  7. Perform GC-FID analyses of raw materials (direct injection) and residual solvents (head space)
  8. Maintain and troubleshoot GC instruments
  9. Perform method validations according to protocols, particularly GC method validations.
  10. Prepare material for shipment to customers.
  11. Represent PPL-SD with a high level of integrity and professionalism.
  12. Adhere to PPL-SD policies and support management decisions in a positive, professional manner.
  13. Keep meticulous and current notebook, logbook and electronic records, related to the work performed.
  14. Be current with all job related trainings.

     

    OTHER JOB FUNCTIONS:

    Perform other duties as assigned, such as, but not limited to

    1.  Perform stability studies testing and keep the related records.

    2.  Initiate and or complete OOS, OOT, Deviation reports, RMS, DSS, Change Controls and     relevant responses to audit findings (CAPAs).

    3.  Create protocols and/or execute method, development, qualification, verification, transfer and validation.

    4.  Provide hands on training on instruments and methods for other analysts.

     

     

    WORKING CONDITIONS:

    Work areas are mostly inside, in a climate-controlled environment with moderate to high background noise and minimal natural lighting.  Sampling of raw materials may take place either outside or in the HMU.  Position involves exposure to hazardous materials, fumes, odors, and dust.

    SPECIAL MATERIAL AND EQUIPMENT USED:

     

Computer

 

Misc. Lab Equipment

 

GC

 

Balance

 

HPLC/UPLC - Analytical

 

Polarimeter

 

Hand Tools

FTIR

pH Meter

 

LC/MS

Elemental (Nitrogen) Analyzer

Karl-Fischer Titrator

 

 

PHYSICAL ACTIVITIES REQUIRED TO PERFORM ESSENTIAL FUNCTIONS:

 

Sitting/Standing/Walking: Approximately 75% of time is spent standing or moving around laboratory work areas. Balance of time (approximately 25%) is spent seated while working at a desk.

Speaking/Hearing: Clear diction and acute hearing are necessary for effective communication with co-workers.

Vision: Corrected vision close to 20/20 is necessary to effectively perform analyses (i.e., measurements, observations, etc.).

Lifting/Carrying/Pushing/Pulling: The ability to lift and carry up to fifty (50) pounds is necessary for transporting bottles, lab equipment, and solvent containers.

Stooping/Kneeling: The ability to stoop and kneel is necessary for accessing equipment from low shelves and containers.

Reaching/Handling: Good manual dexterity is necessary for handling lab equipment and performing essential functions.

 

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

 

  1. Ability to work within the PPL-SD   established safety guidelines
  2. Good written and oral communication skills; ability to communicate effectively and project a professional image when giving and taking information in writing or in person.
  3. Accurate typing/keyboarding skills; solid computer skills, including the use of word processing and spreadsheet software applications.
  4. Knowledge of laboratory techniques.
  5. Minimum two years of hands-on experience of frequent usage of gas chromatographs (GCs) including maintenance and troubleshooting.
  6. Knowledge of cGMP, specifically, ICH Q7A
  7. Ability to take initiative and prioritize tasks; good time-management, problem prevention, and problem-solving skills.
  8. Ability to work independently and as part of a team; ability to motivate self.
  9. Ability to work accurately with close attention to detail.
  10. Ability to maintain confidentiality of sensitive information.
  11. Possess a work ethic that includes neatness, punctuality, and accuracy.

     

     

    QUALIFICATIONS:

     

    Bachelor's degree in Chemistry, Biochemistry, or equivalent scientific discipline.

Or, know someone who would be a perfect fit? Let them know!

San Diego

9395 Cabot Drive
92126 San Diego Directions (858) 408-0808

Perks & Benefits

PolyPeptide presently offers regular full time employees (unless otherwise stated) who have completed the applicable waiting periods the opportunity to participate in employee benefits plans, such as:

  • Group Medical, Dental and Vision Insurance
  • Life Insurance
  • Long-Term Disability
  • Flexible Spending Account
  • 401k Retirement Savings Plan
  • Profit Sharing Plan
  • Employee Assistance Program
  • Paid Holidays (12 Holidays)- 2018

  • Paid Vacation Leave

  • Paid Sick Leave

  • Birthday Off

Our Values

INNOVATION

- We are curious and explore new ways.
- We are ambitious and find solutions.

EXCELLENCE
- We have a strong technical knowledge and we deliver results.
- We deliver quality in everything we do.

TRUST
- We believe in teamwork and collaboration.
- We lead by example and accept responsibility.

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