Job Title: Quality Coordinator - 2nd  Shift

The QA Coordinator schedules work performed by the analysts in the In-Process QA laboratory, responds to out-of-specification (OOS) results found by QA Analysts during in-process monitoring and reviews and approves documentation of the In-Process monitoring.  The QA Coordinator also trains QA Analysts, maintains inventory and controls laboratory and controls laboratory supplies in accordance to department SOPs.  When required, backs up the QA Supervisor in day-to-day activities.  He/she is capable of covering the manufacturing floor in absence of QA Supervision and is also capable of issuing additional Batch record documents when needed by Operations or any other group.  The person in this position is fully qualified to cover the floor as a QA Analyst in times of personnel shortage due to call outs or scheduled time-off.

1. Supervises QA Analysts in absence of QA Supervisor.
2. Attends daily production shift meeting at start of shift and assigns analysts to monitor lines/rooms, O2 headspace testing and comparator work.  Assigns additional work throughout the day including lunch/break coverage.  Schedules and tracks overtime. 
3. Provides initial SOP training and qualification for new hires (temporary and regular).
4. Responds to OOS results and manufacturing deviations.  Recommends immediate corrective action and documents these occurrences in absence of QA Supervision.  This includes but is not limited to notification of Operations personnel and supervision, tagging affected material/equipment, and issuing ERF numbers.
5. Reviews and approves documentation of QA monitoring including Start-ups in a timely manner.
6. Prepares and /or issues Batch record documents when needed.
7. Tracks batch records returned to QA for corrections. 
8. Covers the manufacturing floor in absence of QA Supervision and participates in rotation for weekend coverage.
9. Performs in-process monitoring (Filling room, Inspection/packaging lines, Oxygen headspace testing, and Comparator work) during personnel shortage.
10. Assures laboratory equipment for monitoring is calibrated and ready for use, daily.  Performs or reviews daily balance check and Gas Chromatograph system suitability.
11. Maintains good housekeeping and safe working conditions.  Controls laboratory reagents, supplies and logbooks in accordance to department SOPs.
12. Trains new QA Inspectors.

1. Ability to read and understand documents such as production batch records, safety rules, corporate guidelines and standard operating procedures. 
2. Ability to write routine correspondence. 
3. Ability to speak effectively before employees of various departments and levels of management.
4. Possess basic mathematical skills (addition, subtraction, multiplication, division) and the ability to use a calculator.
5. Ability to have sound judgment and basic analytical skills to enable assessment of risk to issues related to monitoring of the manufacturing floor.
6. Ability to walk from line to line 50% of the shift. 
7. Has good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring. 
8. Has good close visual acuity (eye exam required).
9. Noise levels on production lines may be moderate to high.
10. Ability to be on your feet at least 85% of the shift.
11. Ability to lift 15 pounds.

Work Environment:

Majority of the time is spent in review of paperwork and coordination of QA analyst activities. Has frequent contact with different areas of production and levels of management, in person or via email. Uses laboratory instrumentation, syringes, reagents and compressed gases on a daily basis.

Education and/or Experience:

Bachelor's degree in a Science or equivalent with related Pharmaceutical experience and  >3 year applicable laboratory or pharmaceutical manufacturing experience (QA preferred). OR Associates Degree in Science or related field with 7+ years' applicable experience.

1. Minimum 1 year applicable laboratory or pharmaceutical production experience (QA preferred).
2. Is familiar with cGMPs, CFR and the USP.
3. Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel.
4. Has knowledge of computer systems at a level proficient to navigate input and/or reference computerized data.
5. Must be able to pass the vision requirements established for the Inspector position

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.