SPECTRAFORCE
Base pay range
$35.00/hr - $38.00/hr ???? Work Setup:
ONSITE 100% (N Bites)
No remote work ???? Shift:
12-hour night shifts ( 7:00 PM - 7:00 AM ) on a rotating schedule Candidates who have previously worked a
night shift schedule
would be nice to have. The ideal candidate is someone with
prior experience working night shifts
in a
biotech or pharmaceutical GMP-regulated environment
and is fully comfortable with the
rotating 12?hour schedule (7:00 PM - 7:00 AM) . They should have a strong understanding of
Good Manufacturing Practices (GMP)
and
Good Documentation Practices (GDP)
to efficiently review
batch records, logbooks, and on?floor QA processes . While a
scientific academic background
(e.g., chemistry, biotechnology) is preferred,
hands?on industry experience
can compensate for the lack of a degree. The candidate must be a
strong communicator and a team player , capable of working
cross?functionally
with both the QA and manufacturing teams while effectively documenting and relaying information during shift handovers. Given the challenges past hires have faced in adjusting to the night schedule, a
proven ability to work nights long?term
is critical to ensure continuity in this role. QA Senior Associate
will be responsible for
Quality On the Floor
in support of
Manufacturing activities . This position provides the opportunity to work directly with
Manufacturing staff during bulk drug substance operations
to facilitate
batch record and attachment reviews, logbook reviews, area changeover reviews , and
real?time decision?making regarding quality incidents . This is a unique opportunity to foster a
strong partnership and learning environment
between
Manufacturing and Quality staff . Schedule:
Rotating night shift ( C shift ) with Week 1:
5 days (Mon, Tue, Fri, Sat, Sun) Week 2:
2 days (Wed, Thu) Shift hours:
7 PM to 7 AM, with flexibility as required based on business needs.
Provides
coaching, guidance, and direction
to Manufacturing and Facilities & Engineering staff regarding
compliance and quality systems . Intake Notes How is the shift schedule decided upon each week? Schedule is
pre?determined for the entire year , aligning with
MFG schedule . Its rotating (C shift rotation, 7 days across two weeks, 12?hour shift each night). Team player
and
good communicator Willing to support additional workload by checking with team members Communicates daily priorities and completions Understands when to
escalate events
to management What stands out in resumes: Academic background in Sciences Experience in Quality Assurance or Manufacturing
in Biotech or Pharmaceutical industry Minimum/Maximum education & experience requirements: Bachelors degree + 2 years
of experience (QA or MFG) OR Associates degree + 6 years
of experience (QA or MFG) Experience in
Biotech or Pharmaceutical industry Worked in similar
drug manufacturing organization
within
Quality or Manufacturing
for at least
2 years Academic background
in any
Sciences discipline
Top 3 Must Have Skill Sets
Experience working in
GMP environment
in
Pharmaceutical/Biotechnology
industry Academic background in Sciences Experience working in
Quality/Compliance/Operations
Responsibilities
Provide
Quality oversight
to ensure operations and products are manufactured, tested, stored, and distributed according to
current Good Manufacturing Practices (cGMP) ,
Good Documentation Practices (GDP) , and other applicable regulations Ensure that
facilities, equipment, materials, organization, processes, procedures, and products
comply with
cGMP
and regulations Perform
review and approval
of cGMP processes, procedures, documents, and records (SOPs, Batch Records, Deviations) Author/review/approve
quality documents
such as SOPs, risk assessments, training materials, engineering and automation documents, protocols/reports Ensure changes that could impact
product quality
are properly assessed Ensure deviations are
investigated and documented
per procedures Review
executed batch records, attachments, and area logbooks Ensure
production records and testing results
are complete, accurate, and compliant with procedures and cGMP requirements Alert
senior management
of quality, compliance, supply, and safety risks Complete
required training
to perform assigned tasks Drive
operational improvement initiatives, programs, and projects
Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr
$35.00/hr - $38.00/hr ???? Work Setup:
ONSITE 100% (N Bites)
No remote work ???? Shift:
12-hour night shifts ( 7:00 PM - 7:00 AM ) on a rotating schedule Candidates who have previously worked a
night shift schedule
would be nice to have. The ideal candidate is someone with
prior experience working night shifts
in a
biotech or pharmaceutical GMP-regulated environment
and is fully comfortable with the
rotating 12?hour schedule (7:00 PM - 7:00 AM) . They should have a strong understanding of
Good Manufacturing Practices (GMP)
and
Good Documentation Practices (GDP)
to efficiently review
batch records, logbooks, and on?floor QA processes . While a
scientific academic background
(e.g., chemistry, biotechnology) is preferred,
hands?on industry experience
can compensate for the lack of a degree. The candidate must be a
strong communicator and a team player , capable of working
cross?functionally
with both the QA and manufacturing teams while effectively documenting and relaying information during shift handovers. Given the challenges past hires have faced in adjusting to the night schedule, a
proven ability to work nights long?term
is critical to ensure continuity in this role. QA Senior Associate
will be responsible for
Quality On the Floor
in support of
Manufacturing activities . This position provides the opportunity to work directly with
Manufacturing staff during bulk drug substance operations
to facilitate
batch record and attachment reviews, logbook reviews, area changeover reviews , and
real?time decision?making regarding quality incidents . This is a unique opportunity to foster a
strong partnership and learning environment
between
Manufacturing and Quality staff . Schedule:
Rotating night shift ( C shift ) with Week 1:
5 days (Mon, Tue, Fri, Sat, Sun) Week 2:
2 days (Wed, Thu) Shift hours:
7 PM to 7 AM, with flexibility as required based on business needs.
Provides
coaching, guidance, and direction
to Manufacturing and Facilities & Engineering staff regarding
compliance and quality systems . Intake Notes How is the shift schedule decided upon each week? Schedule is
pre?determined for the entire year , aligning with
MFG schedule . Its rotating (C shift rotation, 7 days across two weeks, 12?hour shift each night). Team player
and
good communicator Willing to support additional workload by checking with team members Communicates daily priorities and completions Understands when to
escalate events
to management What stands out in resumes: Academic background in Sciences Experience in Quality Assurance or Manufacturing
in Biotech or Pharmaceutical industry Minimum/Maximum education & experience requirements: Bachelors degree + 2 years
of experience (QA or MFG) OR Associates degree + 6 years
of experience (QA or MFG) Experience in
Biotech or Pharmaceutical industry Worked in similar
drug manufacturing organization
within
Quality or Manufacturing
for at least
2 years Academic background
in any
Sciences discipline
Top 3 Must Have Skill Sets
Experience working in
GMP environment
in
Pharmaceutical/Biotechnology
industry Academic background in Sciences Experience working in
Quality/Compliance/Operations
Responsibilities
Provide
Quality oversight
to ensure operations and products are manufactured, tested, stored, and distributed according to
current Good Manufacturing Practices (cGMP) ,
Good Documentation Practices (GDP) , and other applicable regulations Ensure that
facilities, equipment, materials, organization, processes, procedures, and products
comply with
cGMP
and regulations Perform
review and approval
of cGMP processes, procedures, documents, and records (SOPs, Batch Records, Deviations) Author/review/approve
quality documents
such as SOPs, risk assessments, training materials, engineering and automation documents, protocols/reports Ensure changes that could impact
product quality
are properly assessed Ensure deviations are
investigated and documented
per procedures Review
executed batch records, attachments, and area logbooks Ensure
production records and testing results
are complete, accurate, and compliant with procedures and cGMP requirements Alert
senior management
of quality, compliance, supply, and safety risks Complete
required training
to perform assigned tasks Drive
operational improvement initiatives, programs, and projects
Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr