SCIENTIFIC PROTEIN LABORATORIES, INC by c9t0f87l

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									                     SCIENTIFIC PROTEIN LABORATORIES LLC

POSITION TITLE:            Quality Assurance Associate Compliance Specialist
DEPARTMENT:                Quality Assurance (760)
REPORTS TO:                Sr. Manager Quality Assurance
CLASSIFICATION:            Exempt, Level 3 (E3)

PRIMARY OBJECTIVE OF POSITION:

Executes written procedures designed to ensure current Good Manufacturing Practice
(cGMP) compliance in such areas as record review and retention; sampling and
evaluating incoming raw materials; sampling and evaluating facility water, air, and other
specified utility systems. Prepares and maintains trend reports. Reviews
manufacturing Batch records. Conducts deviation/discrepancy investigations and
prepares written reports of investigation findings.

DUTIES AND RESPONSIBILITIES:

1. Samples and inspects or directs the sampling and inspection of incoming raw
   materials. Physically quarantines and releases materials subsequent to approval.
   Maintains raw material specifications, reports, and technical information files.
   Coordinates the auditing and qualification of new raw material vendors.

2. Utilizing various techniques and materials, collects facility bioburden samples and
   water samples from designated points within the facility. Updates and maintains
   computer databases of environmental and water monitoring data. Issues reports
   generated from these databases.

3. Assists in the preparation of Standard Operating Procedures (SOPs) covering all QA
   operations. Reviews other facility SOP’s as required.

4. Develops and drafts support documentation (Manufacturing Instructions, etc.) for
   contract and protocol-based manufacturing campaigns. Assists with all related
   departmental documentation.

5. Reviews or coordinates the review of completed batch manufacturing records for
   bulk drug substances for completeness, accuracy and compliance with stated
   process parameters prior to product release.

6. Assists with QA Compliance technician training as needed.

7. Prepares deviation/discrepancy reports and assures completeness of each report
   and supporting documentation. Conducts investigations into the impact of
   deviation/discrepancy events as required.

8. Performs Customer Complaint investigations and writes the report.
Quality Assurance Assoc. Compliance Specialist
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9. Writes Product Protection Plans and audits the plan to assure compliance with the
   plan line items.

10. Assists with Validation activities as needed. Performs other duties as assigned.

JOB STANDARDS:

A. Education: Bachelor’s Degree in Microbiology, Chemistry, or related scientific
   discipline. Degree requirements may be substituted by year-for-year work
   experience in a directly related setting.

B. Experience: One year (minimum) previous laboratory or pharmaceutical quality
   control/manufacturing experience. Not less than two years experience in a Quality
   Assurance environment. Minimum experience requirements may be substituted by a
   education.

C. Standards: Must be able to write and complete reports as assigned; must be able to
   perform routine to moderate mathematical calculations. Must have good attention to
   details and previous cGMP experience is required. Demonstrated proficiency in the
   use of spreadsheets (or word processing/database). Good attendance is required.
   Able to work with little direct supervision.

D. Work Environment: Duties involve use of judgment and initiative. Compliance with
   SOPs and cGMPs required. Demonstrated proficiency in math, reading, typing and
   writing skills, and attention to detail required. Use of dust masks, respirators, and
   protective clothing/equipment may be required to handle a variety of chemicals and
   raw materials. Must be able to schedule time effectively. Extended hours and/or
   some weekend hours may be required.

E. Physical Standards: Job requires stranding, sitting, walking, reaching, bending,
   twisting, and squatting. Use of the hand for fine manipulation and simple grasping
   also required. Fine manipulation and frequent lifting of 1-20 pounds and occasional
   lifting of 21-75 pounds required. Excellent vision, speech, and hearing is required
   for the evaluation of quality characteristic of materials and verbal communication
   with suppliers and clients.

Date Issued:                      Employee Signature:


                                  Department Approval:
AssocComplSpec
Revised 7_2010

								
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