Associate, QC Compliance
Company: Sun Pharmaceutical Industries, Inc.
Location: Billerica
Posted on: October 18, 2024
Job Description:
Job SummaryThe Associate Quality Control - Compliance role is a
dual function role. - The role is divided between QC compliance
activities and QC laboratory GMP testing activities. - Performs
various quality control tests on raw materials, in-process and
final product using approved test methods, Standard Operating
Procedures (SOPs) and works in accordance with current Good
Manufacturing Practices (cGMPs). -Monitors and evaluates systems,
equipment, records and trends data. -Review/revise documentation
(i.e. SOPs). -Works under limited supervision following established
procedures. Timely closure of QMS records, site actions,
implementation of Sun global quality standards, and validity of
departmental SOPs. -Area Of Responsibility -
- Perform release, stability, validation
and complaint (follow-up) analytical quality control tests and
assays on raw materials, in-processing and final products Following
GLPsPerform quality control tests and assays including USP test
methods and EP test methodsMonitor, calibrate, maintain and
evaluate systems or equipment (i.e. water systems, environmental
chambers, analytical instrument/equipment)Analyze data and
interpret results. - Maintain data records in manual or computer
based logs following GDPsMaintain data records in manual or
computer based logs following GDPs
- Support to QC maintained all the time for internal and external
audits following guideline including USFDA, Health Canada, - cGMP,
ISO, GLPs, company policies and procedures. - -
- Support to assure timely closure of quality management system
(QMS) records, site actions, implementation of global quality
standards, and validity of departmental SOPs. - Use of Trackwise to
create, populate, investigate, and close event records (OOS, CAPA,
UPD, PD, CC, etc.). - Investigation leadership will be a plus.
- Send samples to contract laboratories and collect test dataWash
glassware, prepare reagents, solutions, equipment for chemical
tests and assaysAble to operate complex laboratory instrumentation
to analyze product Perform monthly equipment/instrument maintenance
and cleaningFollow work-flow procedures from receiving test
samples, monitoring inventories, to waste disposalTrain towards
Visual Inspection qualificationsOther duties as assigned -Work
Conditions: -
- OfficeLabs with moderate noise, heat,
open flame and radiation in specific areas requiring appropriate
safety equipment (i.e. gloves, lab coat, safety glasses and
respirator)Work with non-hazardous and hazardous chemicals, toxic
metals, cryogenic gases and radioactive materialsExposure to or use
of syringes and needlesRequires access/work in chemical fume
hoodsRequires access/work in class 100K, 10K or 100 clean room
(mask and boots in conformance with environmental dress codes)
-Physical Requirements: -
- Stand, walk, sit, use hands and - fingers to handle or feel,
reach with hands and arms, climb or balance, stoop, kneel, crouch
or crawl, hear and talk
- Close vision
- Lift up to 25 lbs.
- Operate computer/office machines
- Ability to wear Personal Protection Equipment -Travel
EstimateUp to 5% -Education and Job Qualification -
B.S. in a related scientific major
required Good oral and written communication skillsAbility to
follow specific instruction and report assay results (i.e. written
SOPs)Proficient with wet chemical methods and tests (USP, ACS,
Titration, Limit tests, etc.)Fundamental knowledge of chemical
principlesProficient with basic laboratory
instrumentationUnderstanding of cGMPs and GLPsStrong analytical
skills with attention to detailAble to perform basic
troubleshooting and repair of complex instrumentationProficient
computer skills including word processing and spread sheet programs
-Experience
Minimum 2-4 years related experience
Use of Trackwise, Novatech, and Empower software - - -The
presently-anticipated base compensation pay range for this position
is $85,000 to $104,000. Actual base compensation may vary based on
a number of factors, including but not limited to geographical
location and experience. In addition, this position is part of the
Annual Performance Bonus Plan. Employees are eligible to
participate in Company employee benefit programs which include
medical, dental and vision coverage; life insurance; disability
insurance; 401(k) savings plan; flexible spending accounts; and the
employee assistance program. Employees also receive various paid
time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the
terms and conditions of any governing plans, policies, practices,
agreements, or other materials or documents as in effect from time
to time, including but not limited to terms and conditions
regarding eligibility. If hired, employee will be in an "at-will
position" and the Company reserves the right to modify base salary
(as well as any other discretionary payment or compensation
program) at any time, including for reasons related to individual
performance, Company, or individual department/team performance,
and market factors.
The preceding job description has been designed to indicate the
general nature and level of work performed by employees within this
classification. It is not designed to contain or be interpreted as
a comprehensive inventory of all duties, responsibilities and
qualifications required of employees as assigned to this job.
Nothing herein shall preclude the employer from changing these
duties from time to time and assigning comparable duties or other
duties commensurate with the experience and background of the
incumbent(s).
We provide equal employment opportunities for all current employees
and applicants for employment. This policy means that no one will
be discriminated against because of race, religion, creed, color,
national origin, nationality, citizenship, ancestry, sex, age,
marital status, physical or mental disability, affectional or
sexual orientation, military or veteran status, generic
predisposing characteristics or any other basis prohibited by
law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from
agencies and/or search firms for this job posting. Resumes
submitted to any Sun employee by a third party agency and/or search
firm without a valid written & signed search agreement, will become
the sole property of Sun. No fee will be paid if a candidate is
hired for this position as a result of an unsolicited agency or
search firm referral.
Keywords: Sun Pharmaceutical Industries, Inc., Leominster , Associate, QC Compliance, Other , Billerica, Massachusetts
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